Roles & Responsibilities

· Ensure customer satisfaction through promoting excellent service; respond to customer complaints tactfully and professionally

· Analyze staff evaluations and feedback to improve the customer’s experience

· Project future needs for goods and cleaning products; order accordingly

· Oversee health code compliance and sanitation standards

· Seek ways to cut waste and decrease operational costs

· Generate weekly, monthly, and annual reports for the management

· Train new employees and provide ongoing training for all staff

· Attend quarterly P&L meetings

Responsibilities (include but are not limited to):

· Work with the Manufacturing department as a production area Quality Assurance representative

· Coordinate and facilitate Quality Assurance related production and production related activities

· Ensure timely issuance of production records, procedures and labels

· Ensure timely assessment and closure of discrepancies, Deviations and Change Controls

· Review batch-related documentation, and ensure resolution of issues to release product

· Communicate lot disposition pending issues to Management

· Ensure approval and timely delivery of Final Product

· Ensure that products are manufactured in compliance with regulatory and GMP guidelines

· Review and approve Manufacturing and Validation documents for Regulatory and Kite compliance

· Review and approve Manufacturing Production Records

· Compile and verify all batch related documents into a Final Product lot disposition package

· Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues

· Review and disposition disposable raw materials and components for GMP use

· Review equipment and facility technical and investigation reports

· Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies

· Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.

· Perform other duties as required

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• No Experience Needed, Full training/ on the job guidance will be provided
• Able to start immediately

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected] (Attn: QA Specialist)

Thank You.

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

Our client is a well-established MNC, market leader in the 3PL Logistics industry. Due to their current expansion plan, they are looking for Quality Executive, in hopes of developing the current high performing team. They are located in the East - easily assessible.

Responsibilities:

• Conduct daily meetings to address logistics-related manufacturing NCs.
• Validate defects with QC support, providing corrective action recommendations.
• Resolve logistics issues with proper containment and corrective measures.
• Manage complaints, perform root cause analysis, and implement improvements.
• Lead quarterly audits, report findings, and ensure timely closures.
• Prepare quality guidelines and instructions.
• Oversee raw material warehouse quality supporting manufacturing.
• Compile weekly, monthly, and quarterly logistics reports for customer review.

Requirements:

• Min Degree in Supply Chain or related study
• Min 3 years of quality experience in manufacturing setting, well wersed in methodologies such as CAPA, GDPMDS and Six Sigma

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email: [email protected]

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R2198636 (Oh Puey Xin)

Our client is a well-established MNC, market leader in the 3PL Logistics industry. Due to their current expansion plan, they are looking for Quality Executive, in hopes of developing the current high performing team. They are located in the East - easily assessible.

Responsibilities:

• Conduct daily meetings to address logistics-related manufacturing NCs.
• Validate defects with QC support, providing corrective action recommendations.
• Resolve logistics issues with proper containment and corrective measures.
• Manage complaints, perform root cause analysis, and implement improvements.
• Lead quarterly audits, report findings, and ensure timely closures.
• Prepare quality guidelines and instructions.
• Oversee raw material warehouse quality supporting manufacturing.
• Compile weekly, monthly, and quarterly logistics reports for customer review.

Requirements:

• Min Degree in Supply Chain or related study
• Min 3 years of quality experience in manufacturing setting, well wersed in methodologies such as CAPA, GDPMDS and Six Sigma

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email: [email protected]

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R2198636 (Oh Puey Xin)

We are looking for an Executive/Senior Executive, Facilities to join the team.

As an Executive/Senior Executive, Facilities, you are to be an expert in space planning, contract negotiation, and facilities management. The ideal candidate should hold certifications from the Building and Construction Authority (BCA) in building management and fire safety. This role will be responsible for overseeing the efficient operation and maintenance of our facilities, ensuring a safe and comfortable working environment, and optimizing space utilization.

Responsibilities:

- Space Planning

- Develop and execute space utilization strategies to optimize the use of daycare facilities.

- Collaborate with various departments to understand their requirements and plan accordingly.

- Implement space allocation and reallocation plans to accommodate changing business needs.

- Contracts Negotiation

- Negotiate and manage contracts with vendors, service providers, and suppliers for facility-related services.

- Ensure cost-effectiveness and adherence to budgetary constraints while maintaining service quality.

- Monitor and enforce contract compliance, including performance standards and deliverables.

- Facilities Management

- Oversee the day-to-day operation and maintenance of the facilities, including building systems, security, and infrastructure.

- Manage facility service requests, work orders, and repairs, ensuring timely resolution.

- Develop and implement preventive maintenance programs to ensure facility reliability and safety.

- Supervise a team of facility personnel and provide leadership in achieving operational goals.

- Health and Safety Compliance

- Ensure compliance with fire safety regulations and emergency response procedures.

- Conduct regular safety inspections and drills to maintain a safe working environment.

- Collaborate with relevant authorities to obtain and renew necessary safety permits and certificates.

- Budget Management

- Assist in the development and management of the facilities budget.

- Monitor expenses, identify cost-saving opportunities, and report on budget performance.

- Reporting and Documentation

- Maintain accurate records, documentation, and reports related to facility management activities.

- Generate regular reports on facility performance, issues, and improvements.

- BCA Certification Compliance

- Stay up to date with building management and fire safety regulations.

- Ensure that the organization is in compliance with BCA requirements and guidelines.

Job Requirements:

- Bachelor's degree in Facilities Management, Business Administration, or a related field.

- BCA certification in Building Management and Fire Safety.

- Proven experience in facilities management, space planning, and contract negotiation.

- Strong knowledge of building systems, maintenance, and safety regulations.

- Excellent communication and leadership skills.

- Proficiency in using facility management software and tools.

- Ability to work independently and collaboratively, managing multiple projects simultaneously.

- Knowledge of sustainability and energy-efficient practices in facility management is a plus.

- Strong problem-solving abilities and attention to detail.

- Willingness to respond to facility-related emergencies outside of regular working hours.

- Experience in a nursing home environment is an advantage.

• Well Established Company
• Basic $4000 - $4800 + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: East
• Working day: Monday to Friday
• Working hours: 8.30am to 6pm

Job Responsibilities:

• Responsible for quality issues arising from production and customer feedback, and collaborate with the production tea to address internal process issues and implement corrective actions to resolve customer complaints with proper documentation
• Implement the quality inspection standards, on incoming, in process and outgoing inspections, and provide QA inputs to production to resolve quality-related issues at in-process and final inspections
• Responsible for timely closure of Corrective and Preventive Actions (CAPA), non-conformance investigation report and customer complaints and, publish reports on quality performance
• Lead the Material Review Board (MRB) meeting involving members from production, engineering and quality departments to conduct root cause analysis, address quality issues, implement corrective actions and review its effectiveness
• Lead the team of QC inspectors in the inspection of parts for conformity in accordance with relevant drawing requirements
• Perform any other duties, as assigned

Job Requirements:

• Minimum Diploma or Degree in Precision Engineering, Quality Management or Mechanical Engineering with 2 years of working experience in quality engineering or manufacturing

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.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

Roles & Responsibilities

· Ensure customer satisfaction through promoting excellent service; respond to customer complaints tactfully and professionally

· Analyze staff evaluations and feedback to improve the customer’s experience

· Project future needs for goods and cleaning products; order accordingly

· Oversee health code compliance and sanitation standards

· Seek ways to cut waste and decrease operational costs

· Generate weekly, monthly, and annual reports for the management

· Train new employees and provide ongoing training for all staff

· Attend quarterly P&L meetings

Roles & Responsibilities

· Ensure customer satisfaction through promoting excellent service; respond to customer complaints tactfully and professionally

· Analyze staff evaluations and feedback to improve the customer’s experience

· Project future needs for goods and cleaning products; order accordingly

· Oversee health code compliance and sanitation standards

· Seek ways to cut waste and decrease operational costs

· Generate weekly, monthly, and annual reports for the management

· Train new employees and provide ongoing training for all staff

· Attend quarterly P&L meetings

Roles & Responsibilities

· Ensure customer satisfaction through promoting excellent service; respond to customer complaints tactfully and professionally

· Analyze staff evaluations and feedback to improve the customer’s experience

· Project future needs for goods and cleaning products; order accordingly

· Oversee health code compliance and sanitation standards

· Seek ways to cut waste and decrease operational costs

· Generate weekly, monthly, and annual reports for the management

· Train new employees and provide ongoing training for all staff

· Attend quarterly P&L meetings

Roles & Responsibilities

· Ensure customer satisfaction through promoting excellent service; respond to customer complaints tactfully and professionally

· Analyze staff evaluations and feedback to improve the customer’s experience

· Project future needs for goods and cleaning products; order accordingly

· Oversee health code compliance and sanitation standards

· Seek ways to cut waste and decrease operational costs

· Generate weekly, monthly, and annual reports for the management

· Train new employees and provide ongoing training for all staff

· Attend quarterly P&L meetings

Roles & Responsibilities

· Ensure customer satisfaction through promoting excellent service; respond to customer complaints tactfully and professionally

· Analyze staff evaluations and feedback to improve the customer’s experience

· Project future needs for goods and cleaning products; order accordingly

· Oversee health code compliance and sanitation standards

· Seek ways to cut waste and decrease operational costs

· Generate weekly, monthly, and annual reports for the management

· Train new employees and provide ongoing training for all staff

· Attend quarterly P&L meetings

Roles & Responsibilities

· Ensure customer satisfaction through promoting excellent service; respond to customer complaints tactfully and professionally

· Analyze staff evaluations and feedback to improve the customer’s experience

· Project future needs for goods and cleaning products; order accordingly

· Oversee health code compliance and sanitation standards

· Seek ways to cut waste and decrease operational costs

· Generate weekly, monthly, and annual reports for the management

· Train new employees and provide ongoing training for all staff

· Attend quarterly P&L meetings

Roles & Responsibilities

· Ensure customer satisfaction through promoting excellent service; respond to customer complaints tactfully and professionally

· Analyze staff evaluations and feedback to improve the customer’s experience

· Project future needs for goods and cleaning products; order accordingly

· Oversee health code compliance and sanitation standards

· Seek ways to cut waste and decrease operational costs

· Generate weekly, monthly, and annual reports for the management

· Train new employees and provide ongoing training for all staff

· Attend quarterly P&L meetings

Roles & Responsibilities

· Ensure customer satisfaction through promoting excellent service; respond to customer complaints tactfully and professionally

· Analyze staff evaluations and feedback to improve the customer’s experience

· Project future needs for goods and cleaning products; order accordingly

· Oversee health code compliance and sanitation standards

· Seek ways to cut waste and decrease operational costs

· Generate weekly, monthly, and annual reports for the management

· Train new employees and provide ongoing training for all staff

· Attend quarterly P&L meetings

Job Description

• To coordinates the process of product registration and market access approval in the designated countries including providing all required documents and certificates within the specified timeframe proactively to complete product registration.
• To provide advice to internal and external teams in interpreting relevant guidance documents and standards.
• To contact local authority and organization for both regulatory problems solving and obtain updated information on current and developing regulations.
• To review and approve documents to support Post Market Change notification (including labelling changes) to comply with international regulations and standards.
• To remain up to date on regulations and communicate any key changes to stakeholders in the broader organization.
• To provide training when necessary and assist with the development of the respective countries’ Regulatory Affairs infrastructure to facilitate greater speed to market.
• To take charge of QA (complaint reporting etc) for all subsidiaries.

Qualification

• Degree/ Diploma in Biomedical engineering or science or QA/RA related field
• Minimum progressive 3 years of QA/RA working experience in medical device manufacturing industry

Interested candidate, please email to [email protected]

Leon Leong De Cong

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599

Your Role

• Perform checks on the structural, architectural and M&E materials/works to ensure that the final touch-up works are ready for inspections
• Monitor the performance of subcontractor workers for all trades and ensure any defects are properly rectified
• To participate, work closely and give support to safety personnel at site on all initiatives/ matters relating to Safety and Health
• To comply with the Company Safety Management System and the WSHA and its subsidiary legislation

The Requirements

• Possess a Degree in Civil Engineering or its equivalent
• Minimum 3-5 years of relevant working experience in construction industry
• Must be technically inclined and possesses excellent problem-solving
• Be able to work independently as well as acquiring good interpersonal skills to coordinate between the various disciplines and construction teams

Our Client is in the Aviation Industry. Due to their current expansion plan, they are looking for an Quality Engineer to join their team, in hopes of developing the current high performing team. They are located in the East.

Responsibilities;

• Ensure product and process quality by managing the Quality Management System (QMS) in compliance with government regulations, aviation authority standards, and customer requirements.
• Update and refine quality procedures and control instructions to align with operational and regulatory standards.
• Collaborate with customers, vendors, and suppliers to address non-conformance issues.
• Perform root cause analysis and implement corrective actions to reduce poor quality costs.
• Conduct internal audits to evaluate compliance with ISO 9001, AS9100, and NADCAP standards.
• Carry out vendor and on-site audits as required to ensure quality performance.
• Ensure strict adherence to customer and regulatory authority standards and specifications.
• Lead efforts to minimize the cost of poor quality and reduce scrap through effective quality management practices.
• Any ad-hoc duty as assigned

Requirement

• Min Degree in Mechanical or Aeronautical Engineering
• Min 2 years experience in ISO9001 / AS9100 Quality Management System and NADCAP process
• Experience and knowledge in fishbone diagrams, FMEA and 5-whys methodology
• Able to read and interpret technical and blue print drawings

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R21103987 (Yan Yongmao)

Responsibilities:

• Validation quality review of lifecyle documents and protocols for Automation CSV qualification, EFU qualification, cleaning validation, laboratory equipment qualification, and IT systems qualification.
• Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines timely
• Review and approve as needed, qualification/validation executed package validation exceptions, deviation, and investigations encountered during qualification/validation representing Quality
• Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities
• Participate in site Validation Maintenance Program
• Any other tasks as and when assigned by supervisor
• Support other technical changes and duties as require

About You:

• Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science
• At least 5 years qualification/validation experience
• Possess process automation experience will be the additional benefit to be considered
• Communicate well, self driven, motivated and able to work well with others
• Based in Tuas

Job Type: Contract

Contract length: 9 months

Roles & Responsibilities

· Ensure customer satisfaction through promoting excellent service; respond to customer complaints tactfully and professionally

· Analyze staff evaluations and feedback to improve the customer’s experience

· Project future needs for goods and cleaning products; order accordingly

· Oversee health code compliance and sanitation standards

· Seek ways to cut waste and decrease operational costs

· Generate weekly, monthly, and annual reports for the management

· Train new employees and provide ongoing training for all staff

· Attend quarterly P&L meetings

Roles & Responsibilities

· Ensure customer satisfaction through promoting excellent service; respond to customer complaints tactfully and professionally

· Analyze staff evaluations and feedback to improve the customer’s experience

· Project future needs for goods and cleaning products; order accordingly

· Oversee health code compliance and sanitation standards

· Seek ways to cut waste and decrease operational costs

· Generate weekly, monthly, and annual reports for the management

· Train new employees and provide ongoing training for all staff

· Attend quarterly P&L meetings

Support day-to-day training administration for the Company. Interacts with all levels of staff in the Company with regards to in-house training, external training, on-the-job training and education.

Training Needs Analysis and Training Plan

• Compile the Training Needs for the year
• Analyze the training needs of staff and develop a total training plan yearly
• Educate or provide awareness training on Training Needs Analysis as required

Training Management and Communication

• Upkeep of all staff training records
• Conduct/Coordinate on training such as ISO9000, AS9100, ISO14000, OHSAS18001, Technical training, Soft Skills & etc.
• Assist in program design and development for in-house training
• Source, evaluate and engage external consultants for selected training programs
• Create training awareness & schedule through internal promotion, intranet & etc.
• Liaise with government institution for training grants or subsidies
• Review and recommend policies and procedures to increase the effectiveness and efficiency of the people development functions
• Control and monitor the total training budget for the company
• Set up an information system for the people development function to provide pertinent feedback to management

Training Evaluation

• Compile all training evaluation results after each training
• Provide monthly reports on training results, expenditure & etc.
• Develop and evaluate all four levels of training and ensure prompt feedback of information
• Provide half-yearly training report on the Total Training Plan and its effectiveness
• Comply with the ISO9001, AS9100, ISO4001 & OHSAS18001 Management system

Other Tasks

• Familiar with Quality Control Circle criteria and able to conduct and facilitate the teams.
• In charge of Staff Suggestion Scheme and ensure all employees to participate during Quality month
• Involve in GHG reduction activities
• Submit OHS & HSE data to HQ quarterly
• Other tasks assigned by superior.
• Ensure implementation of people development policies and procedures
• Timely compilation of Training Needs Analysis of the company yearly
• Implementation of training identified in the Total Training Plan
• The Company Education budget is appropriately used

Requirements:

• Degree in Business Administration with 2 years related experiences or Diploma in Training & Development with 4 –5 years training experience
• Possess good interpersonal skills
• Good oral & written communication skills
• Able to work as a team player
• Knowledge in People Developer Standard & it’s requirements
• Computer literate & proficient in MS Office
• Good understanding of Training Fund on all government statutory board requirements
• Stand up training experience is essential.

5 days work week

Bedok Area

Manufacturing Co.

Interested candidates, please forward a detailed resume and email to [email protected]

Tempserv Pte Ltd
License No: 06C3745
Attention: Audris Teo / EA Personnel No: R1102063

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

Senior HR Executive/ HR Executive

Visit https://ourengineers.com to apply or submit your CV for more job opportunities.

Job Description:

Learning and development

Support the planning and implementation of learning and development plans and programs

Coordinate and liaise with respective vendors on programs sourced and planned for.

Oversee the BCA CET A1 program by ensuring active monitoring of CPD/PDU hours acquired by identified staff for the required year.

Liaise and coordinate with higher education institutions and BCA on scholarship and internship programs

Understand actively maintain the requirements of the ISO9001 certification program in conjunction with the QESH team.

Recruitment

Develop job descriptions in consultation with the hiring manager on the position

Advertise and actively manage prospective candidate screening for profiling to respective hiring managers.

Schedule interviews and perform assessment on candidate fit for recommendation to HR Manager and hiring manager.

Compensation

Perform compensation and benefit total package proposal in consultation with HR Manager and hiring manager before making an employment offer proposition to the identified shortlisted candidate.

Conduct the onboarding and orientation program to ensure the employee is seamlessly introduced to the staff and resources for effective employee integration.

Employee Engagement

Support the roll out and coordination of employee engagement programs and events (e.g. quarterly newsletter publication, lunch talks, town hall talk, festive celebrations)

Manage internal company wide announcements and communication on programs and events, and drive successful adoption rate of programs.

Requirements:

Degree in HRM with at least 5 years of relevant experience, preferably from Construction industry.

Proficient in performing stand-up delivery for learning programs, briefings, and onboarding program.

Proficient in MS Word/Powerpoint/Excel

Email: [email protected]

MOM EAP : R1102601

Website : www.OurRecruiters.com

Singapore - MOM EA Lic. : 14C7308

Job Description:

1. Schedule and assign specific duties / roles to cleaners and lead team members to perform cleaning activities. Ensure cleaners to adhere to the cleaning standard and procedurer.

2. Experience of operating cleaning machines, scrubbers, hi-jet, etc; and provide training to cleaners when necessary.

3. Control and monitor the usage of cleaning materials to avoid or minimizewaste and/or misuse.

4. Daily report to operations manager onthe job site situation

5. Help operations manager and be thefirst contact person to handle any complaints and feedbacks from Clients.

6. Any other duties assigned by operations manager.

Job Requirements:

1. At least 3 years' experience in similar role in cleaning sector.

2. Hardworking attitude, able to work atheight and move 20 Kgs of weight.

3. Able to work overtime including weekends and public holidays; willing to alternate between Night and Day shift when required.

4. Able to float to work in island wide locations.

5. Able to use simple Office Software and willing to undertake paperwork duties aswell.

6. Good attitude and hard working. Must be physically fit.

7. Long hour standing jobs.

Quality Assurance Manager (Biopharma/CBD/1 Year Contract)

Role Purpose:

The Responsible Person, Quality Assurance Manager Australia and New Zealand, will work collaboratively with relevant stakeholders to implement & maintain the local Australian and New Zealand QMS and will work with internal & external stakeholders to ensure quality requirements are met for organisation products, throughout the distribution network, and within Australia and New Zealand, all the way to patients.

Key Responsibilities:

• Establishes and maintains the Quality Management System in Australia and New Zealand to ensure that it meets local regulatory and industry standards and organisation expectations.
• Support maintenance of relevant licenses.
• Manages local process of change control, deviation, CAPA, complaint management and supplier management.
• Manages local Quality Management Review process.
• Participates in organisation’s Quality Escalation process for critical quality issues, and regulatory compliance issues.
• Ensures up to date organograms, training curricula pertaining to GMP/GDP, training records, CVs, and Job Descriptions are in place for local affiliate personnel working on quality/distribution matters.
• Establishes and maintains the Affiliate Quality Manual and GMP/GDP procedural documents.
• Establishes and maintains the Quality Agreement with 3PL/4PL and local GMP/GDP related suppliers/service providers, as required.
• Reviews Annual Product Quality Reports (if applicable)
• Ensures shipping conditions match the product license/product label particulars and transporters are appropriately qualified.
• Ensures premises and/or equipment used are reviewed regularly to ensure they are adequate to allow the handling, storage, and distribution of medicinal products in a manner that ensures the maintenance of product quality.
• Supports Customer Services with enquiries of a GDP nature such as delivery issues, transportation conditions, disputes, etc.
• Working with 3PL/4PL, provides guidance on supply related issues.
• Arranges authorized relabeling/repackaging in cooperation with 3PL/4PL (where applicable)
• Supports the management of quality and distribution complaints.
• Supports the investigation of fraudulent and counterfeit medicinal products.
• Manages product return and destruction.
• Manages local recalls and participating in supplier’s recall challenge or perform local mock recall, as needed.
• Qualifies and manages local 3PL/4PL and supports audit of 3PL/4PL.
• Qualifies and manages local GMP/GDP related suppliers/service providers, auditing and approving these according to local requirements.
• Assure customers validations and adequate records compliance to organisation QA requirements are established and maintained for all local distributors/customers.
• Collaborates with RA to support inspections and audits.
• Manages the Affiliate self-inspection program.
• Supports audit of distributor (where applicable).
• Collaborates with RA to implement activities for new product launch and product life cycle management.

Knowledge, Experience & Skills:

• Highly organized individual with a strong work ethic and ability to work flexibility and independently.
• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Distribution Practices (GDPs) and knowledgeable about the specific requirements for Australia and New Zealand.
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
• Demonstrates proficiency in Quality Systems processes (Deviation, CAPA, Change Control, Complaints, etc.)
• Demonstrates a knowledge of regional/local regulatory requirements and industry standards.
• Demonstrates strong verbal, written, and interpersonal skills in English.
• Demonstrates proficiency in Microsoft Office applications, particularly, WORD, Excel, PowerPoint, and Teams. Familiarity with technology platforms such as Veeva Vault, SAP ERP, etc.
• Working knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is preferred.

Typical Educational Experience & Competencies

• Bachelors’ degree and 7+ years of relevant experience in a GMP or GDP environment-related field
• Masters’ degree and 5+ years of relevant experience in a GMP or GDP environment related field.
• Ability to work on own initiative as well as display strong teamwork skills.
• Demonstrates clear personal responsibility for own work, in terms of both the quality of the work and the manner in which it is performed. ‘
• Ability to support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organisational strategy.

EA License No. 01C4394 • RCB No. 200007268E •EA Registration No. R22109454 Malcolm Lee Jun Hao

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