Quality Control Supervisor – Raw Materials

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).

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.