Quality Assurance Support (Pharma | Contract)
1 month ago
About our client: Our client is a leading global pharmaceutical manufacturing company.
*Please note that this role will be hired on a 6-month' contr..
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
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