Total 4 technical support job vacancies in Quality Assurance / Control category in Singapore

About our client: Our client is a leading global pharmaceutical manufacturing company.

*Please note that this role will be hired on a 6-month' contract to support our client's project.

*Work Location: North

*Working days: 5 days

About the role:

• Revise and Review SOPs (Standard Operating Procedures): Review and update existing SOPs to ensure they are aligned with current regulatory requirements, industry standards, and best practices. Collaborate with cross-functional teams to assess the relevance of existing procedures and recommend necessary revisions or improvements. Ensure that all SOPs are thoroughly reviewed, approved, and communicated to the relevant teams.
  
• Review Executed MBR/EBR (Master Batch Records/Equipment Batch Records): Perform detailed reviews of executed MBRs and EBRs to ensure that all steps and activities have been completed per specifications and compliance requirements.
  Identify and document any discrepancies or non-conformances and work with the manufacturing team to resolve them promptly.
  Provide feedback and support for improving the execution process to ensure quality compliance.
  
• Support Manufacturing Team with Quality Interpretation, Queries, and Issues: Act as the point of contact for the manufacturing team to address any quality-related queries, issues, or interpretations of quality standards and procedures. Provide guidance on resolving non-conformances and assist in implementing corrective and preventive actions (CAPAs).
  Work collaboratively with manufacturing, production, and other departments to ensure quality concerns are addressed in a timely and effective manner.
  
• Provide Quality Oversight (GEMBA Walks, GMP Walks):Actively participate in GEMBA walks and GMP walks to observe and assess current manufacturing practices, identify areas for improvement, and ensure compliance with quality standards. Monitor and report on the execution of manufacturing processes, ensuring adherence to established quality protocols. Provide on-the-spot quality guidance and corrective actions when necessary to ensure adherence to GMP.
  
• Perform Archival of Quality Operations (QO) Documents: Manage and ensure the accurate archival of all Quality Operations (QO) documents, including batch records, SOPs, validation protocols, and test records. Ensure that archived records are organized, easily retrievable, and comply with all regulatory and internal standards. Assist in the preparation of documents for audits and inspections as required by internal and external regulatory bodies.

About you:

• Education: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field. Equivalent work experience may be considered.
• Experience:Minimum of 5 years of experience in Quality Assurance or related roles within the pharmaceutical, biotechnology, or manufacturing industries.
  Familiarity with GMP, SOPs, batch records, and other relevant quality control practices. Experience in document control, archiving, and handling quality documents.

Skills & Abilities:Strong understanding of regulatory requirements (e.g., FDA, EMA) and GMP guidelines.
Ability to interpret quality-related documents and SOPs.
Strong attention to detail and organizational skills.
Ability to communicate effectively across departments and with external stakeholders. Proficiency in Microsoft Office and quality management software (e.g., LIMS, QMS) is preferred.

*Please note that only shortlisted candidates will be contacted.

EA Name: Kingsforce Management Services Pte. Ltd.

EA License: 94C3545

EAP Name: Paola Jane Ofrasio Fajardo

EAP Reg. No: R1325507

Quality Lab Support Coordinator (Pharma)

Duration: 6 months contract

Location: Tuas

Salary : Up to $2,500 depending on experience

Our Client is a US MNC and a pioneering leader in the Pharmaceutical industry. They are currently seeking experienced and forward-thinking professionals to join their Team in Singapore

Responsibilities

• Receive, archive, retrieve and dispose retention sample, following standard work, approved procedures and regulatory requirements in timely manner.
• Maintain proper 5S and ensure inspection readiness of retention sample rooms.
• Perform assigned tasks within stipulated timeline and escalate discrepancies to Reporting Manager.
• Support laboratory supplies stock check, receiving, stock arrangement and disposal as necessary.

Requirements:

• At least O Level qualification and good communication skills
• Proficient handwriting and computer literacy
• Able to work independently and escalate any issues if needed
• Able to move heavy boxes up to 15kg / use heavy ladder for the work to transfer samples/stock checking etc

Lim Pey Chyi – [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423

Administered by the Workforce Advancement Federation (WAF), the Career Conversion Programme (CCP) for Biomedical Manufacturing Executives is a premier talent development initiative designed to cultivate the next generation of skilled professionals for Singapore’s Biomedical manufacturing industry. This comprehensive 15-month programme features structured on-the-job training (OJT) provided at Novartis Singapore Pharmaceutical Manufacturing Pte Ltd (NSPM), facilitating the practical application of acquired knowledge and ensuring participants develop the essential competencies required for their roles.

Eligilibity for CCP:

• Singapore Citizen or Permanent Resident;

• Minimum 21 years old;

• Mid-Career Individual: Graduated, or completed National Service, whichever is later, for at least 2 years* prior at the point of application; or

• Fresh Graduate: Graduated, or completed National Service, whichever is later;

• Not in a similar job function prior to joining Career Conversion Programme (CCP);

• Have not attended the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously;

• Have not been funded under the same programme – Career Conversion Programme (CCP) for Biomedical Manufacturing Executives / Professionals (Train-and-Place with Commitment to hire) – previously.

• Should not be shareholders, immediate ex-employees of Novartis, or be related to shareholders of Novartis.

Successful candidates must be able to commence the program by March 2025.

Job Purpose

Responsible for providing quality oversight to ensure smooth manufacturing operation and new product launches/transfer in a compliant and timely manner. Support drug substance batch review and release in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objective/s.

Key Responsibilities

Operational

a. Provide Quality oversight to site operations/objectives

· Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance.

· Participate/Support meetings (as required) and team tiered process to monitor/detect/act on anomalies to key site quality KPIs and continuous improvement.

b. Review/ Release of Raw materials and manufactured materials

· Perform and be responsible in ensuring Batch record review and/or release (raw materials and manufactured materials – for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards

· Support the release team in batch release in ensuring batch release (manufactured materials – for authorized person only) is in full cGMP compliance to regulatory and Novartis Quality Standards.

c. Support exception investigations and change control activities

· Lead/support in ensuring a smooth manufacturing operations in production/QC/Logistics, in handling deviations/capa, change control, complaints, customer management, escalation, recall etc are in full cGMP compliance to regulatory and Novartis Quality Standards

d. Support OpEx improvement projects

· Support for end-to-end lifecycle management, timely review & escalation, stakeholder management to achieve agreed outcomes for projects assigned and areas under responsibility

e. New Product Introduction

· Support in ensuring success to new product launch/transfer and equipment/product lifecycle management are in full cGMP compliance to regulatory and Novartis Quality Standards e.g., Product Transfer, Equipment Qualification, Computerized System Validation, Shipping Validation, Cleaning Validation, , Process Validation, Ongoing Process Verification & etc

f. Customer Management

· Lead/support network/project governance meeting and team tiered process to monitor/detect/act on anomalies to project milestones, KPIs and continuous improvement.

· Support in preparing customers request documentation or requests

g. Documents review

· Provide support (Review/Approval) of GMP Record/Document in ensuring compliance to regulatory and Novartis Quality Standards

h. Inspections

· Provide support in ensuring inspection readiness. Support customer, internal Novartis and Health Authority audits.

i. Any other task/duties assigned by Line Manager

Requirements

· University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)

· Several years of experience in pharmaceutical quality control, quality assurance or production or relevant quality experience. Fresh graduates are welcome to apply.

· Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice

· New entrants to biopharmaceutical industry and should not be holding a bond obligation with any organisation

Job Responsibilities:

• Read telex and action accordingly.
• Inform apron of aircraft changes, edit in CRO Editor and send CALL BACK to all concerned.
• Ensure requests for SIA stretcher/ Supplementary Oxygen kit and update in stretcher/ Supplementary Oxygen Kit chart-update the systems.
• Update flight observer chart and fax to IGO and provide a copy to MAINTROL.
• Any last-minute aircraft change less than 2 hours to STD, CRO will call refuellers directly and inform of aircraft change.
• Prepare SQ and Scoot (including Line Station) Delay reports.

Job Requirement:

• Minimum ITE Certificate in any discipline
• Familiar with Microsoft excel and SAP
• Experience in performing coordination, data entry, and generating reports
• Able to quick response to any last minute’s aircraft changes and react promptly
• Possess good communication skills
• Able to work under pressure
• Comfortable with rotating shift (12hrs Morning & Night) pattern based on 2 days’ work and follow by 2 days off work arrangement.