Quality Control Supervisor – Raw Materials

11 days ago 2026/11/10 ·Application closes in 108 days

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Job description

1. Laboratory Oversight & Operations

Supervise and coordinate daily QC testing activities within the Raw Materials section.
Plan, schedule, and allocate routine and non-routine testing to meet material release timelines.
Ensure timely analysis and approval of raw materials to support uninterrupted manufacturing operations.
Monitor laboratory housekeeping, safety practices, and compliance with EHS requirements.
Ensure the availability, calibration, qualification, and proper maintenance of analytical instruments used for raw material testing (e.g., FTIR, Raman, UV-Vis, HPLC, GC, and wet chemistry).

2. Review, Approval & Data Integrity

Review and approve raw data, analytical results, specifications, Certificates of Analysis (COAs), and test reports.
Ensure compliance with ALCOA+ data integrity principles across all laboratory records and electronic systems.
Review and approve transactions and analytical results in SAP/LIMS, ensuring accurate maintenance of vendor-related data.
Perform trend analysis of raw material and water testing results to identify recurring issues and opportunities for improvement.
Maintain and periodically review the approved raw material vendor list.

3. Quality & Compliance

Ensure compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), ICH guidelines, pharmacopeial requirements (USP/EP), and internal SOPs.
Maintain inspection readiness and participate in internal and external regulatory audits (e.g., FDA, EMA, SFDA, WHO).
Investigate and document Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and non-conformances, ensuring timely closure with effective CAPAs.
Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
Participate in supplier qualification and requalification activities, including vendor audits, COA verification, and supplier performance monitoring.

4. Documentation & SOP Management

Oversee the preparation, review, approval, issuance, and periodic revision of SOPs, analytical methods, logbooks, forms, and templates.
Ensure all QC documentation is accurate, complete, controlled, and fully traceable.
Prepare and review analytical reports and provide QC documentation to support Regulatory Affairs submissions.
Ensure documentation practices comply with data integrity requirements and support audit readiness.

5. People Management & Training

Lead, mentor, supervise, and evaluate QC analysts within the Raw Materials section.
Ensure effective onboarding, technical training, competency assessments, and continuous professional development of laboratory personnel.
Conduct performance evaluations, support succession planning, and address employee performance and conflict resolution as required.
Foster a culture of quality, accountability, teamwork, and continuous improvement.
Maintain audit readiness by ensuring ongoing staff training in data integrity, GMP, and regulatory compliance.

6. Continuous Improvement & Performance Management

Drive laboratory efficiency through continuous improvement initiatives, including Lean, Six Sigma, automation, and digitalization projects.
Establish, monitor, analyze, and report Quality Control Key Performance Indicators (KPIs).
Promote cost awareness and optimize laboratory resources to improve productivity and operational efficiency.
Identify opportunities to streamline laboratory processes while maintaining compliance, quality, and data integrity.

Qualifications & Experience

Bachelor's degree in Pharmacy, Chemistry, or a related scientific discipline (Master's degree preferred).
13–15 years of Quality Control experience in the pharmaceutical industry, including a minimum of 5 years in a supervisory or leadership role.
Extensive knowledge of pharmacopeial requirements (USP, EP, BP, and JP) related to raw material testing.
Hands-on experience with analytical techniques used for raw material testing, including FTIR, Raman spectroscopy, UV/Vis spectrophotometry, HPLC, GC, wet chemistry, and pharmacopeial identification and assay methods.
Thorough understanding of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), ICH guidelines, and regulatory inspection requirements.
Proficiency in SAP, LIMS, and electronic laboratory documentation and data management systems.
Demonstrated experience in regulatory inspections, audit preparation, supplier qualification, and quality risk management.
Strong analytical, problem-solving, and decision-making skills with the ability to manage multiple priorities in a GMP-regulated environment.
Excellent leadership, communication, coaching, and cross-functional collaboration skills.
Proven ability to drive continuous improvement initiatives and effectively manage laboratory performance through quality metrics and KPIs.

This job post has been translated by AI and may contain minor differences or errors.

Years of experience

No experience required

Degree

Bachelor's degree / higher diploma

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