MiRXES is a Singapore-headquartered molecular diagnostic company with R&D, manufacturing, and clinical lab operations in Singapore, USA, Japan, and China. We specialize in microRNA technologies and the development, manufacturing, and provision of diagnostic test kits and clinical services. Our mission is to enable early disease detection and provide insights for better patient care by harnessing the power of microRNA to augment traditional testing. Our vision is to be the world’s leading developer and provider of accurate, actionable, and affordable microRNA-powered diagnostic tests.

Job Location: Tukang

Job Summary

The QC Specialist will work as part of the Quality team to support the QC of day-to-day operations and maintain detailed records for all the tasks assigned. The individual will inspect the products in different stages of manufacturing process such as incoming raw materials, intermediates, in-process and finished good. The individual will also participate in the investigation of nonconforming products and follow-up with the actions that arises from these inspections.

Roles and Responsibilities

• Perform routine QC testing of incoming materials, inprocess materials and finished goods.
• Plan and schedule daily QC routine and ad hoc runs assigned by QC supervisor.
• Evaluate data and create reports, highlighting any notable deviations from current standard operating procedures.
• Raise nonconformance for failures resulting from QC runs.
• Support troubleshooting/investigation of nonconformance to determine root cause of the failure.
• Responsible in drafting/revising of QC work instructions.
• Support validation and stability studies across lab development and Diagnostic products, if necessary.
• General lab support including housekeeping, equipment maintenance, document archival, maintaining logbooks and inventory of lab reagents, etc.
• Contribute to the continuous improvement of laboratory procedures and processes to ensure compliance to GMPs.
• Apply good documentation practices on all records for better traceability, transparency, and the purpose of auditing.
• All listed tasks and responsibilities are deemed to be essential to the functions, but business conditions may require reasonable accommodations for additional task and responsibilities.

Desired Skills and Competencies

• Degree/ Diploma in Biomedical Science, Biotechnology, Molecular Biology, Biochemistry, Life Science related courses or equivalent.
• Have qPCR knowledge and experience in using qPCR machine.
• Proficient with the use of standard equipment such as pipette,
• centrifuge, etc.
• Familiar with the basic laboratory procedures. Relevant experience with laboratory testing, and QC of assays-based workflow will be an advantage.
• Able to work independently with minimal supervision and with others within and outside his/her function.
• Excellent organizational and time management skills.
• High degree of initiative and ownership.
• Possess a positive and willing-to-learn attitude.
• Good interpersonal and communication skills.
• Basic computer competency, including familiarity with Microsoft Office, is highly desirable.
• 2-3 years of relevant experience in quality control and preferably in medical device manufacturing industry.
• Good understanding of GDP and cGMP are preferred.

We appreciate your interest in the above-mentioned position, however, due to overwhelming response, only shortlisted candidates will be contacted.

We are looking for a detail-oriented and meticulous individual to join our team as a Branded Goods Quality Control cum Packing Specialist. The successful candidate will be responsible for ensuring the quality and accuracy of branded goods, as well as performing packing and packaging tasks according to company standards.

Key Responsibilities:

1. Quality Control:Conduct thorough inspections of branded goods to ensure they meet quality standards and specifications.
   Identify any defects, discrepancies, or imperfections in the products and document them accurately.
   Communicate quality issues to the appropriate personnel and assist in resolving them.
   
2. Quality Assurance:Implement quality assurance procedures and protocols to maintain consistency and reliability in product quality.
   Monitor and enforce quality control standards throughout the packing process.
   
3. Packing and Packaging:Prepare and pack branded goods for shipment or distribution according to packing instructions and guidelines.
   Select appropriate packaging materials and methods to ensure product safety and integrity during transit.
   Label and mark packages accurately with relevant information, such as product details, quantities, and destination.
   
4. Inventory Management:Assist in inventory management tasks, including counting, labeling, and organizing branded goods in the warehouse or storage area.
   Keep accurate records of inventory levels and report any discrepancies or shortages to the supervisor.
   
5. Documentation:Maintain detailed documentation of quality control activities, packing procedures, and inventory transactions.
   Complete packing and quality control forms, checklists, and reports as required.
   
6. Compliance:Ensure compliance with company policies, procedures, and safety regulations at all times.
   Adhere to quality control standards and guidelines set by the company and regulatory authorities.
   
7. Team Collaboration:Collaborate with other team members, including warehouse staff, supervisors, and logistics personnel, to ensure smooth operations and timely order fulfillment.
   Communicate effectively with team members to coordinate tasks and prioritize workload.
   

Requirements:

1. Experience: Previous experience in quality control and packing, preferably in a warehouse or manufacturing environment, is desirable.
2. Attention to Detail: Exceptional attention to detail and accuracy in inspecting, packing, and labeling branded goods.
3. Organizational Skills: Strong organizational skills with the ability to prioritize tasks and manage time effectively.
4. Communication Skills: Good verbal and written communication skills for conveying information and reporting issues.
5. Team Player: Ability to work collaboratively as part of a team and support team goals and objectives.
6. Physical Stamina: Ability to stand, bend, lift, and move heavy objects as required in a warehouse environment.
7. Adaptability: Willingness to adapt to changing priorities and work in a fast-paced environment.
8. Ethical Conduct: Commitment to upholding ethical standards and integrity in all work activities.

This is an exciting opportunity for an individual with a keen eye for detail and a passion for quality to play a vital role in ensuring the integrity and excellence of our branded goods. If you meet the requirements and are ready to contribute to our team's success, we encourage you to apply for the position of Branded Goods Quality Control cum Packing Specialist.

About the role :

Key responsibilities

• Maintain QC Raw Materials laboratory in full cGMP compliance.
• Lead raw material method validation/ verification and routine release testing
• Plan day to day operational activities in QCRM (i.e., housekeeping, release testing). Perform data entry, review and approval of RM packages for batch release
• Lead improvement projects and perform technical reviews of procedures and testing monographs for raw materials
• Lead laboratory investigations (e.g., OOS, deviation) and lead change controls for QC Raw Materials
• Lead creation and revisions of RM testing monographs
• Prepare and participate in health authority inspections and internal audits
• Other duties or projects assigned by the QC Team Leader – Raw Materials

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements

Essential Requirement:

• University degree in Pharmacy or Chemistry or equivalent
• 5-10 years relevant experience in Pharma/Manufacturing sector in analytical lab in a GMP environment
• Experience in Raw Material Lab and Method validation
• Handling quality metrics & issues Knowledge of GMP Management of Quality Audit, Quality Change, Control Good Documentation

Why consider Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and
extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse,
equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we
collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Packing Specialists | Quality Checker | Macpherson

Working hours：
If 5 days ($1400.)
Mon – Thurs 9am-7pm. Friday 9am-6pm
If 6 days ($1600.)
Mon – Thurs 9am-7pm. Friday – Sat 9am-6pm.

$100 increment after pass 3 months probation
Working Location: Office/HQ – Macpherson

Job Responsibilitis:

QUALITY CONTROL & PACKING DUTIES:

1. Conduct service audits and quality control checks with an eye for detail and service assurance
2. Advise Operations Dept and teams on irregularities or potential issues
3. Collect and maintain inspection/QC records

Detailed process of packing

1. Check Receipt - conditions of bags
2. Check pics (before pics) to confirm condition of bags (highlight any obvious defects or irregularities not in receipt)
3. Check services are completed. Areas of service are done properly (e.g. colour touchup areas)
4. Check colouring areas has not stained metal hardware. If there is, to clean off
5. Check HP coating - for obvious pressure mark or stains
6. Check cleanliness of bags that are cleaned, esp in hidden areas (e.g. handles, inside or corners of pockets)
7. Check the receipt if have any accessories (e.g. dustbags, tags) and that these are packed together in paper bag back to shop or back to customer home via delivery
8. Check metal hardware is clean/shiny - to do metal polishing (if cotton bud or cloth is still dirty, to do more extensive polishing)
9. Check inside fabric lining is cleaned
10. Check all leather parts are properly cleaned and add leather conditioner or polish if needed
11. Check if long straps/accessories are clipped back on the bag/returned to original position
12. Use paper stuffing to prop up shape of the bag
13. Use Teddy bear scent if bag has still mouldy smell
14. Use tracing paper to pack and protect the exterior of the bag or handles/straps (esp. For Hp coating bags or for bags that are soft leather/lambskin/sensitive leather)
15. PATENT - do not condition, only polish, pack with tracing paper
16. Check MODE of delivery is to shop or to home delivery
17. Make sure item is placed properly for home delivery or for internal delivery to shops

AIM:

1. Customer satisfaction after item is serviced
2. Checking that conditions of bag is the same
3. Checking that parts and accessories are all assembled properly and packed tog for return
4. Making sure of QC or quality of service is good

The Supreme HR Advisory Pte Ltd | 14C7279

Ong Boon Kiet (Travys) | R22104769

Senior Recruitment Consultant

Trade Compliance Project Specialist

1 year contract, with potential to renew/ convert

Come and join us!

Do you wish to work in a world-class organization trying your hands at something you have dreamt of doing?

“FIND YOUR PLACE” by joining a world-class US Consumer company

Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, competitive salary and bonus, and endless amenities and benefits.

Company Description:

Our client is an American consumer health company. It is the proprietor of well-known consumer brands. They combine the power of science with meaningful human insights to empower people around the world to live healthier lives

As ASPAC Regional Supply Chain Deliver and Trade Operations Specialist you will:

Be a regional specialist who provides project management capability in Asia Pacific (ASPAC) for legal entity name changes (LENC) within the space of supply chain under Deliver and Trade Operations.

The primary responsibility of this individual is to plan, lead and harmonise cross-functional activities and milestones for LENC, while ensuring no operational disruptions.

The individual will collaborate closely with ASPAC market Deliver and Trade Operation leads, ASPAC PMO, and other regional functions.

Key Responsibilities:

• Plan LENC project’s timeline (critical milestones) and checklists within the areas of Warehouse, Freight Transportation, Trade Operations / Compliance and Customer Service.
• Coordinate LENC projects with market’s Deliver and Trade Ops leads to ensure final project objectives (FPOs) are achieved and measured through effective transfer of knowledge, and process / systems.
• Monitor interdependencies, with risks properly highlighted and escalated through Deliver or ASPAC channels.
• Liaise with market / regional Deliver and Trade Ops, as well as cross functional colleagues to steer the transition throughout all LENC projects.
• Ability to understand markets’ existing export and import trade regulations.
• Sound knowledge on ASPAC Trade Compliance requirements, regulations, and impact from LENC activities towards Customs / Statutory Bodies Rules & Regulations & understanding of International Logistics
• Ensures effective integration of global trade compliance processes and standards within region.

Key measures

The position will be measured primarily on:

• Final Project Objectives (FPOs) achievements such as:

o Completion of LENC within execution timeline

o Proper transition from old to new LE with minimal or no downtime in market operations

o Cost for market’s LENC is within the allocated budget.

o Ensure compliance standards across organisation’s trade operations

• Interactions and collaborations with colleagues in ASPAC in driving execution, resolving issues and leveraging resources.

Requirements:

• University / Bachelor's Degree or Equivalent with minimum 2 years of work Experience relating to Supply Chain or Trade Compliance / Operations
• Awareness of quality / compliance, supply chain, operations, and logistics
• Project management experience
• Ability to work with local site teams and senior leadership

Preferred

• Knowledge in the application of trade and customs regulations for ASPAC markets is highly desirable
• Cross-functional experience, with at least one supply chain pillar (Plan, Make, Source, and/or Deliver)
• Experience interacting and collaborating with teams across business functions and regions
• Process oriented with strong critical thinking / problem-solving skills
• Results oriented and able to independently create and deliver; self-starter / entrepreneurial

Interested parties, please apply through this link https://jnj-apac.talent-pool.com/projects OR click on APPLY button.

Alternatively, you can share your CV at [email protected]

EA License: 94C3609

Reg No: R1440247

Glencore Singapore Pte Ltd is a wholly owned subsidiary of Glencore International Plc. and engages in commodity trading. The Singapore office employs approximately 220 staff working from a single site.

We are looking for a Compliance Due Diligence Specialist to join the team.

KEY RESPONSIBILITIES

· Providing support to the Regional Compliance with respect to due diligence of business partners, including but not limited to:

• Sending relevant Due Diligence questionnaires for new and existing counterparties using the Glencore platform and assign reviews to the relevant Compliance team members.
• Assisting counterparties with the completion of the external questionnaire.
• Attending to request to update counterparty’s information by liaising with the data management team overseas.
• Conducting KYC (know your counterpart) reviews of new overhead vendors (non-trade), including screening using available online tools.
• Completing open-source checks (media, regulators lists etc.) and raise potential red flags to more senior team member for KYC and TPDD (third-parties) profiles.

· Tracking and updating information in the Compliance platform (CGR) in relation to Trainings and implementation of Compliance documents.

· Assisting with logistical arrangement of Compliance training and events such as booking of venues, running slides, etc

· Prepare communication for the the roll out of relevant policies, procedures and guidelines in the region.

· Coordinate with the Corporate Compliance team based in Switzerland and UK and other function team members on the implementation of the program.

· Sending New Joiner’s Compliance Form and keeping records of joiners and leavers.

· Other Compliance tasks, as required for the implementation of the programme.

KEY COMPETENCIES/ SKILL SETS

· Proficient in MS Office

· Strong organizational skills and the ability to multi-task, prioritise and complete tasks with accuracy and attention to detail

· Can work proactively and is a team player

· Self-motivated, enthusiastic and demonstrates a high level of trust and integrity

· Flexible, able to work under pressure.

· Fluent in English (any additional Asian language is a plus)

EDUCATION AND EXPERIENCE REQUIREMENTS

Minimum:

· University degree in Law, Finance or Accounting

· With some experience in Compliance and Trade Finance roles, ideally with due diligence knowledge

· Experience using screening systems such as WorldCheck, Factiva or others.

· Fresh graduates are welcome to apply

COMPENSATION

Salary will commensurate with qualifications & experience.

We regret to inform that only shortlisted candidates will be notified.

JOB SUMMARY

Marriott’s Digital Quality Assurance team is tasked with maintaining high quality and User experience for our digital channels. Quality of our digital products is critical for providing our Loyalty members and guests with the latest information about our brands, hotels, and programs while they use the platforms to manage their reservations. This position works with Corporate Digital eCommerce teams to ensure the completion of Marriott.com Digital/ User Acceptance Testing for projects across Digital Channels. Conducts linguistic, functional, visual, Accessibility and device testing for assigned projects. Assist in QA process for the development and Content changes going out on Marriott Digital Channels.

REQUIREMENT

- Bilingual in English and Korean to translate the content of Marriott.com from English to Korean

- Min 2 years Quality Assurance experience for IT applications/ eCommerce websites preferred

- Working knowledge of Atlassain tools (Jira, Confluence and Zephyr) and programming skills is a plus

Job Responsibilities:

• Conduct various testing and analyses promptly.
• Analyze bulk product, in-process, raw material, or environmental samples following Standard Operating Procedures and Test Methods.
• Document results in compliance with current Good Manufacturing Practices (cGMP).
• Troubleshoot analytical methods and equipment issues.
• Participate in method transfers, validation, equipment qualification, and technical selection of QC equipment, standards, and reagents.
• Analyze assay trends, revise and update documents.
• Provide general lab support, including housekeeping, equipment maintenance, and inventory management.
• Undertake any other duties assigned by your Supervisor/Manager.

Requirements:

• Possess a Degree/Diploma in a relevant Chemistry or Science field, or equivalent.
• Have relevant work experience in a laboratory setting.
• Proficient in HPLC, Empower software, ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, TOC, Protein concentration (A280 or SoloVPE), osmolality, potency methods, appearance, and other physiochemical methods.
• Familiar with cGMP regulations.

Healthcare Quality & Regulatory Compliance Specialist (Hybrid) AMEA

Opportunity:

Play a critical role in driving compliance and quality programs for Healthcare Transportation and facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Your Contribution:

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Provide inputs to support the design & implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead and support various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead regular audit programs / random checks to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and support in issue resolution via conducting root cause analysis (depot).

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

What we look for in you!

1. Hold local pharmacist license (and may be required to hold licenses and permits on behalf of the company)

2. Have three (3) to five (5) years of relevant experience in pharmaceutical or healthcare industry in a quality related role

3. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.

5. Experience in conducting external and internal audits

6. Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute.

Your competencies:

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Job Title: Quality Control Specialist in Jurong Island

Job Description:

• To perform routine analysis of polymer testing & wet chemistry analysis.
• To ensure that tests assigned are performed in a timely manner in accordance with validated test protocols and procedures.
• To perform instruments’ calibrations, maintenance, and troubleshooting.
• To perform housekeeping and maintain the cleanliness in the laboratory.
• To perform inventory check & improvement idea in the lab.  To assist superiors with non – routine study samples and any other tasks assigned

Job Requirements: -

• Diploma in Chemical Process Technology / Chemical Engineering.
• Preferred candidates with min. 1 year of relevant working experience in the Laboratory fields (chemical / pharmaceutical industry) or fresh Poly graduates are also welcomed.
• Hands-on experience in operating laboratory equipment such as injection molding & gas chromatography will be an added advantage.
• Team player, good integrity and willingness to learn as training will be provided.

Other Information

• 5 days' Work Week from 8,30am - 5.30pm
• Willing to work in Jurong Island starting 8.30am
• Company transport provided at Outram Park and Jurong East MRT station.
• Must be able to work overtime when required.
• Basic Salary ranging from $2500 - $3200.
• AWS + Variable Bonus (UP 3-4 mths)
• Jurong island site allowance $220 + Transport allowance $140

If you possess the above-mentioned Chemical process with Lab experience and you like what you see, interested applicant.

Kindly send in your resume. We regret only shortlisted candidates will be notified.

EA License No. 14C7092

EA Registration No: R1110882

EA Personnel: Lee Ming Er

1. Perform daily periodic checks of Central Kitchen to ensure compliance to in-house GMP/GHP standards, SOP, Product Specifications, etc.

2. Conduct random checks on incoming raw materials, and perform product cutting on raw materials to ensure goods received are within in-house specifications.

3. Ensure Process Verification and Validation exercise are completed (i.e. SOP/CCP verification, new product launch process observation, monthly facility checks, monthly traceability exercise, finished goods shelf-life verification, etc.)

4. Conduct investigations on product/process non-conformance (on-line and customer complaints) and follow-up on proposed corrective/preventive measures to ensure effectiveness.

5. Promptly follow-up with contractors (chemical/pest control) during routine servicing to ensure work orders are conducted as per contract.

6. Participate and engage in quality system implementation (audit activities by regulatory/certification bodies and customers).

7. Conduct data/trend analysis on non-conformity of raw material/finished goods, pest reporting statistics, monthly production and facility check statistics, etc. for process and quality improvement.

8. Ensure analysis of food products via microbiological and physical testing, calibration of lab equipment and measurement tools, internal sensory evaluation are conducted as per schedule.

9. Report all non-conformances, discrepancies and/or deviations, and follow-up on the investigation of the non-conformity results.

10. Other projects as assigned.

5 days work week in Jurong Island

Working Hours: 8:30am to 5:15pm

Transport Pick up from Jurong East MRT / Outram Park

Job Descriptions:

• To perform routine analysis of polymer testing & wet chemistry analysis.
• To ensure that tests assigned are performed in a timely manner in accordance with validated test protocols and procedures.
• To perform instruments’ calibrations, maintenance, and troubleshooting.
• To perform housekeeping and maintain the cleanliness in the laboratory.
• To perform inventory check & improvement idea in the lab.
• To assist superiors with non – routine study samples and any other tasks assigned

Job Requirements:

• Diploma in Chemical Process Technology / Chemical Engineering.
• Preferred candidates with min. 1 year of relevant working experience in the
• Laboratory fields (chemical / pharmaceutical industry) or fresh Poly graduates are also welcomed.
• Hands-on experience in operating laboratory equipment such as injection molding & gas chromatography will be an added advantage.
• Team player, good integrity and willingness to learn as training will be provided.
• Must be able to work overtime when required.

QA Specialist (QMS/ Validation/ BioTech/ Pharma)

Duration: 6 Months Contract (Convertible)

Location: Tuas

Salary : Up to $7000 depending on experience

Our client is a fully integrated, global immunotherapy powerhouse who have been working on automated and digitized processes and build continuously capabilities for specialized manufacturing, either for individualized vaccines or for large-scale products like COVID-19 vaccine.

Responsibilities

• Responsible to review and approve validation protocols, reports, risk assessment and other validation related documents for equipment’s, computerized systems, HVAC & utility systems, process validation, Analytical & Microbiology methods etc.
• To ensure validation documents are compliance with internal procedure or regulatory requirements.
• Responsible to review and approve specification documents in compliance with validation requirements.
• Support the review of the validation related standard procedures.
• Support internal and external audit inspection.
• Quality oversight for validation maintenance program.
• Collaboration with cross functional team for site improvements
• Adherence to safety requirements

Requirements:

• Degree in pharmaceutical science or related discipline.
• A minimum experience of 3-5 years in Pharmaceutical in the field of Quality Assurance or Validation.
• Hands-on experience on validation / qualification of manufacturing equipment’s/ systems etc.
• Deep knowledge on various validation regulatory guidelines such as FDA/EU cGMP, PDA Technical guide, GAMP requirements etc.
• Knowledge on Data Integrity and Compliance with cGMP

Lim Pey Chyi (Apple) - [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423

Jobscope

• Responsible to review and approve master batch records and subsequent batch records
• Review and approve cleaning records and procedures and ensure compliance with set
• Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Develop and maintain document control process for efficient management and record all documentation
• Ensure proper document classification, sorting, filing and proper archiving
• Performs document quality check in accordance to company ISO document control procedures.
• Review and maintain the accuracy of the records, editing where necessary to ensure they are up to date.
• Undertake various functions related to document control, document archiving, document imaging and maintenance of document register
• Provide administrative support on the area of drafting document control and documentation.

Requirements

• Diploma/ Degree in Science or any related Engineering
• Quality Assurance experience is advantageous
• Pharmaceutical GMP / Lifescience environment will be highly preferred

Apply now by sending your resume to [email protected] for more enquiries.

We regret to inform you that only shortlisted candidates will be notified.

Tammy Yap | Outsourcing Team | EA License Number: 99C4599

Recruit Express Pte Ltd Company Reg. No. 199601303W

Job Scope:

• Perform the role of Lead Investigator into incidents to which you have been assigned. In doing so, it is necessary to immediately:
  • Visit the area where the incident has been detected (if applicable, e.g. if detected internally in an operational setting)
  • Discuss with all involved in the incident to gain a full understanding of the process and incident per GQA.003
  • Gather background information (or coordinate accordingly) regarding the reported incident
• Perform an initial impact assessment in a timely manner. Identify immediate action to be taken in order to ‘ring-fence’ the problem and ensure it is not further exacerbated whilst the investigation is ongoing.
• Liaise with personnel within various departments / sites and encourage individuals to be forthcoming with pertinent information to facilitate the investigation. This may involve Lead Investigators in other areas or at other sites.
• Host internal meetings (locally or globally, as applicable) and co-ordinate brain-storming sessions to advance the investigation.
• Use appropriate Root Cause Analysis tools (as applicable) to establish causes and any contributory factors.
• Determine the communication strategy and effectively liaise with the PL /PM (as applicable) and all other relevant parties to appraise them of the investigation as it progresses (where applicable). This may extend to include notification of customers, VPs, Key Account sponsors, BD, Commercial Contracts, Quality Management and the QPs (as applicable).
• Escalate to department manager and Quality management any critical issues that become apparent during the course of the investigation that may not have been immediately obvious.
• Determine appropriate and meaningful CAPA to prevent recurrence. Gain agreement of such with department managers (locally or globally, as applicable).
• Document the investigation in the appropriate template. Ensure the report is written to a high standard and that every effort is made to ensure it is Right First Time and acceptable to the customer and the regulators.
• Proactively monitor the progress of all investigations assigned to you and prioritise accordingly. Take responsibility and ownership for such endeavoring to ensure close out in a timely manner. Escalate any that are overdue.
• Perform CAPA effectiveness checks as required in a timely manner and provide the necessary evidence of such to Quality.
• Host or participate (as applicable) in external teleconferences / meetings / regulatory inspections to discuss particular incidents, should additional explanation or assurance be needed. Ensure all such contact, oral and written, is carried out professionally in order to develop and maintain good relationships.
• Promote good inter-departmental and global relationships. Work within and across functions and sites as necessary to assure global consideration of investigations and the CAPA arising from such.
• Endeavor to approach problems with a positive attitude and as an opportunity for company to continuously improve.
• Attend all necessary training and retain a thorough knowledge of processes / procedures pertinent to the area you represent.
• Update KPIs and capture trending information at a department level, ensuring there is good visibility of this data globally. Remain observant of recurring issues, taking such into consideration at the point of an investigation and escalate to management as applicable.
• Meet regularly with management to discuss KPI and trending data. Present ideas / suggestions for consideration into further process improvements.
• Attend periodic meetings with other Lead Investigators locally and globally. Be forthcoming with ideas / experiences to ensure shared learning and continuous improvement.
• Ensure documentation is generated and completed in accordance with the principles of GMP and internal SOPs.
• Fulfil any necessary duties associated with the role, as and when required.

Requirement

• Has prior QA background with focus on report generation and reviews
• Able to engage multiple stakeholders independently.
• Min. Degree in Science
• Has prior pharma background will be an advantage

If interested, please email your resume to [email protected]
➖
Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)

Healthcare Quality & Regulatory Compliance Specialist (Hybrid) AMEA

Opportunity:

Play a critical role in driving compliance and quality programs for Healthcare Transportation and facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Your Contribution:

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Provide inputs to support the design & implementation of robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead and support various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead regular audit programs / random checks to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and support in issue resolution via conducting root cause analysis (depot).

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead and support validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

What we look for in you!

1. Hold local pharmacist license (and may be required to hold licenses and permits on behalf of the company)

2. Have three (3) to five (5) years of relevant experience in pharmaceutical or healthcare industry in a quality related role

3. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

4. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices, IATA CEIV and other local certifications in a warehouse and transportation business.

5. Experience in conducting external and internal audits

6. Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute.

Your competencies:

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility in one of 6 areas: Quality Systems, QA Engineering, External QA, QA Excellence (Transformation and Technical Compliance), Quality Operations or Audit Management.

Key responsibilities:

• Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility.

• Display a good level of problem-solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience.

• Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections.

• Take on role of QA Specialist in Quality Operations.

• In depth awareness of entire process, identifying operational factors which influence the process.

• Review and approve change controls.

• Review and approve Master Batch Records (MBR), SOPs, protocols, reports or records.

• Support changeover activities.

• Support Annual Product Quality Review activities.

• Can trouble-shoot and able to weigh up all information and consideration in order to choose the optimum path to be taken.

• Demonstrate ability to lead a small project and manage the deliverables effectively.

• Develop good working relationships with internal & external customers.

• Able to participate actively or lead in investigations, change controls, CAPA plans and closure of discrepancy reports.

• Develop skills as an internal GxP auditor, as required.

• Provide support in regulatory inspections and customer audits as required.

• Plan for future activities and coordinate with other departments to complete this.

• Develop skills to be Qualified Trainer in area of expertise.

• Any other tasks as and when assigned by supervisor.

Key requirements:

• Bachelor's degree with exposure in the Biopharmaceutical industry.

• Relevant experience from the Biopharma or any related environment.

• Hands-on experience coordinating & interacting with internal departments on manufacturing activities.

• Knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.

• Meticulous and Systematic.

• Team player, with strong focus on safety, quality and timelines.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

We provide company transport, both ways, at multiple pick up points.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Create, review and approve Good Manufacturing Practices {also cGMP} validation documentation.
• Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
• Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
• Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
• Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.

Qualifications

Must-Have

• Bachelor's Degree
• Experience in Quality administered systems
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills

Nice-to-Have

• Experience at a manufacturing site
• Experience of writing and managing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

• Calibration of pressure, temperature, pH and instruments in laboratory and customer sites.
• Familiar with CMC table and able to calculate CMC and uncertainties for pressure and temperature.
• Lab/ onsite ISO-17025 calibration jobs.
• Familiar with ISO/IEC 17025: 2017 & ISO 9001: 2015 requirements.
• Assist in lab audits
• Ad hoc duties

Requirements:

• Min Diploma/Degree in Engineering
• Min 2-3 years of laboratory experience in pressure, temperature and PH testing methods
• Familiarity with a quality system such as ISO 17025 or ISO 9001.

Interested & qualified applicants, please forward your latest CV in MS word format to [email protected]

Jobscope

• Responsible to review and approve master batch records and subsequent batch records
• Review and approve cleaning records and procedures and ensure compliance with set
• Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Develop and maintain document control process for efficient management and record all documentation
• Ensure proper document classification, sorting, filing and proper archiving
• Performs document quality check in accordance to company ISO document control procedures.
• Review and maintain the accuracy of the records, editing where necessary to ensure they are up to date.
• Undertake various functions related to document control, document archiving, document imaging and maintenance of document register
• Provide administrative support on the area of drafting document control and documentation.

Requirements

• Diploma/ Degree in Science or any related Engineering
• Quality Assurance experience is advantageous
• Pharmaceutical GMP / Lifescience environment will be highly preferred

Apply now by sending your resume to [email protected] for more enquiries.

We regret to inform you that only shortlisted candidates will be notified.

Tammy Yap | Outsourcing Team | EA License Number: 99C4599

Recruit Express Pte Ltd Company Reg. No. 199601303W

Job Descriptions

- Perform hands on pest control work on customers' sites

• Attend to Clients' complaints on pest issues and understand the potential causes of pests' activities

• Conduct on-site routine reviews to Client's premises to check on the quality of the technical team and ensure Company's SOP and Protocol are followed thru' by technicians.

• Prepare ad-hoc / monthly formal reports to clients with recommendations for remedial actions for enhanced protection of their premises.

• Attend meetings with technical team as well as NEA inspectors on site.

• Do presentations during meetings in front of customers/NEA officers to review pest issues

• Implement on work plan, Risk Assessment, Safe Work Procedures, hygiene standards to ensure compliance with Workplace Safety & Health Environment.

• Maintain mandatory records and other documentations for Bizsafe Level 3 Certification.

• Strong knowledge on General pests & safety regulations will be an added advantage.

• Proficient in MS Office.

• Ability to lead

• Good command of English

• Minimum 4 years experience in the relevant field.

• NEA Pest Management Licence preferred

• Must have Class 3 driving licence

• Able to start work immediately or short notice.

• Must be prepared to be on standby duty 24/7 even on weekends or public holidays

• MNC Company
• Basic $2500 - $3200 + Allowance + AWS + VB + Excellent Benefits
• Excellent Welfare and Benefits + Career progression
• Working days: Monday to Friday
• Working hours: 8.30am to 5.15pm
• Jurong Island. Company Transport provided
• Training provided for those without/lesser experience

Job Responsibilities:

• To perform routine analysis of polymer testing & wet chemistry analysis
• To ensure that tests assigned are performed in a timely manner in accordance with validated test protocols and procedures
• To perform instruments’ calibrations, maintenance, and troubleshooting
• To perform housekeeping and maintain the cleanliness in the laboratory
• To perform inventory check & improvement idea in the lab
• To assist superiors with non – routine study samples and any other tasks assigned

Requirements:

• Diploma in Chemical Process Technology / Chemical Engineering
• Willing to work overtime when required

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

THIEN CHING MEI (R2198032)

EA Recruitment Pte Ltd

EA License No: 21C0492

• Willing to work in Jurong Island
• Monday to Friday from 8.30am to 5.15pm
• Company pickup transport provided at Outram Park and Jurong East MRT station
• fresh graduates with no experience are also welcomed to apply
• Fixed allowance up to $360 (transport and site)
• Must be able to work overtime when required

The Challenges:

• To perform routine analysis of polymer testing & wet chemistry analysis.
• To ensure that tests assigned are performed in a timely manner in accordance with validated test protocols and procedures.
• To perform instruments’ calibrations, maintenance, and troubleshooting.
• To perform housekeeping and maintain the cleanliness in the laboratory.
• To perform inventory check & improvement idea in the lab.
• To assist superiors with non – routine study samples and any other task assigned

What it Takes:

• Diploma in Chemical Process Technology / Chemical Engineering.
• Preferred candidates with min. 1 year of relevant working experience in the Laboratory fields (chemical / pharmaceutical industry)
• Hands-on experience in operating laboratory equipment such as injection molding & gas chromatography will be an added advantage
• Team player, good integrity and willingness to learn as training will be provided

Interested Applicants, please submit a copy of your updated resume (in MS Word Format) and send to [email protected]

Sarah

Reg No: R2198293

EA License No: 21C0501

*We regret to inform that only shortlisted candidate will be notified. Thank you

QC Specialist

Highlights:

• Industry: Manufacturing
• 5 days’ work week; 8.30am – 5.15pm
• Remuneration: Up to $3200 (Depending on experience)
• Location: Jurong Island
• Transport (2 ways) provided at : Jurong East OR Otram Park MRT Station

The Challenges:

• To perform routine analysis of polymer testing & wet chemistry analysis.
• To ensure that tests assigned are performed in a timely manner in accordance with validated test protocols and procedures.
• To perform instruments’ calibrations, maintenance, and troubleshooting.
• To perform housekeeping and maintain the cleanliness in the laboratory.
• To perform inventory check & improvement idea in the lab.
• Other ad-hoc duties as assigned.

What it Takes:

• Min. Diploma in Chemical Process Technology / Chemical Engineering or equivalent
• Candidates with min. 1 year of experience are preferred
• Candidates with no experience are welcome to apply too (Training will be provided)
• Hands-on experience in operating laboratory equipment such as injection molding & gas chromatography will be an added advantage.
• Able to commit to OT occasionally as and when required

Interested candidates please kindly send your updated CV to [email protected]

Talents@Work Pte Ltd

EA License Number : 21C0501

Rei: R2199207