QA Specialist / Pharma GMP / Up to S$3.8k / Jurong / Contract (Training Provided)

QA Specialist / Pharma GMP / Up to S$3.8k / Jurong / Contract

(Training Provided)

Summary

Reporting to the QA Manager (QMS), the Quality Management System Specialist oversees site quality systems to ensure GMP and corporate compliance. The role supports quality assurance activities, drives continuous improvement, manages key QMS processes (including document control, training, supplier management, product quality reviews, and data integrity),identifies and mitigates quality risks, and helps deliver regulatory and client commitments. The position also provides quality system expertise, supports cGMP compliance, and coaches colleagues to strengthen quality practices across sites.

Responsibilities

· Responsible for writing relevant procedures and reviewing all SOPs from other functional teams.

· Ensure the safety message that the first goal of all employees is safety is implemented and lived throughout their organization and bolster this throughout the facility as possible.

· Ensure QMS system(e.g. TrackWise, eDMS, SFLMS etc.) is configured and maintained to support GxP compliance. Authors SOPs / Work Instructions related to QMS.

· Maintain site change control system, develop effective change control evaluation methodology, oversee and coordinate the execution of site change control procedure, to ensure all changes which will potentially impact product quality are appropriate evaluated and effective controlled.

· Maintain site CAPA system, including but not limited to designing effective actions and effectiveness check methodology, ensure actions completed on time, and coordinate effectiveness check for actions.

· Manage corporate standards gap assessment at site level, ensure site practice compliant with regulatory requirements.

· Maintain document and record management system, develop department document control and cross function document champion team, oversee and coordinate the effective execution of site document management requirements. Ensure document execution compliant with site management requirements, guide and oversee supplier for record archival, ensure all C&Q executed records are archived.

· Maintain GMP training system, develop cross function training champion team, oversee and coordinate the effective execution of site training and personnel qualification.

· Develop annual training plan. Introduce, develop and improve site GMP training modules.

· Develop annual product quality review plan; perform product quality review as planned; trend analysis and take necessary CAPAs etc.

· Execute site self-inspection program, to ensure site practice compliant to cGMP and corporate policies, and work on continues improvement of site compliance. It includes but not limited to: Develop site self-inspection annual plan, coordinate and participate site self-inspection, perform periodic review and trend analysis for this program, and also develop site GMP auditors.

· Coordinate and complete Inspection readiness activities to ensure site ready for both client and regulatory audits at all times.

· Participate in hosting client and regulatory audit, responsible for timely and effective execution of external audit commitments. Interact with SMEs in all functional areas of the site to manage their response to any findings and their timely commitment to address those findings within CAPA and other quality systems.

· Support site management review process, collect quality data, analyze compliance performance trend, be able to identify and manage the metrics, and responsible for continues improvement.

· Provide quality oversight on site supplier management program, manage Quality Agreement and supplier change control, participate in Material Certification and Supplier selection/evaluation as quality representative.

· Maintain and track all QMS events to close within due dates without any overdue records.

· Maintain site data integrity system and oversight of effective implementation across the site.

· Execute any other related work assigned by company.

EHS

· Understand and ensure implementation of emergency procedures and safe systems of work.

· Ensure compliance with environment, health and safety rules, signage, and instructions at all times.

· Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Requirements/Qualifications

Experience:

· 1 - 3 years of relevant Quality experience in pharmaceuticals a plus.

· Experience in Quality Management System, Track Wise specifically an asset.

· Experience in biologics and aseptic training is an asset.

· Experience in site data integrity management is an asset.

Competencies:

· Knowledge in cGMP and Regulatory Compliance and GMP Quality Management System.

· Effective Systematic Thinking and Communication ability.

· Good Coordination and Collaboration.

· Effective execution and result driving.

· Good at problem solving and Quality Risk Management knowledge and tool.

Education:

• Bachelor’s Degree in Life Sciences or Chemical/Biochemical engineering, Pharma related Scientific Area

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