QC Supervisor

Laboratory Oversight & Operations

Supervise and coordinate daily QC testing activities in the raw materials section.

Plan, schedule, and distribute routine and non-routine work to meet release timelines.

Ensure timely analysis and approval of raw materials to support uninterrupted production.

Monitor laboratory housekeeping, safety, and adherence to EHS requirements.

Ensure availability, calibration, and qualification of instruments used in raw material analysis (FTIR, Raman, UV, HPLC, GC, wet chemistry, etc.).

Review, Approval & Data Integrity

Review and approve raw data, analytical results, specifications, COAs, and test reports.

Ensure compliance with ALCOA+ data integrity principles across all records and systems.

Approve results and transactions in SAP / LIMS and maintain vendor-related data.

Conduct trend analysis of water and raw material testing results to identify patterns.

Maintain and periodically review the raw material vendor approval list.

Quality & Compliance

Ensure adherence to cGMP, GLP, GDP, ICH, USP / EP requirements, and internal SOPs.

Participate in internal / external audits (FDA, EMA, SFDA, WHO, etc.) and ensure inspection readiness.

Investigate and document OOS, OOT, deviations, and non-conformances, ensuring timely closure with effective CAPAs.

Support and monitor the implementation of the Quality Management System (QMS).

Participate in supplier qualification and requalification, including vendor audits and COA verification.

Documentation & SOP Management

Oversee the preparation, review, issuance, and periodic revision of SOPs, logbooks, and templates.

Ensure all QC documentation is controlled, accurate, and traceable.

Prepare and review analytical data reports and provide QC support for Regulatory Affairs submissions.

Ensure compliance with documentation requirements for data integrity and audit readiness.

People Management & Training

Lead, mentor, and evaluate QC analysts in the raw material section.

Ensure onboarding, technical training, and continuous development of staff are conducted and documented.

Conduct performance evaluations, succession planning, and conflict resolution as needed.

Foster a culture of quality, accountability, and continuous improvement among team members.

Ensure team readiness for audits by maintaining consistent training in data integrity and regulatory compliance.

Continuous Improvement & KPIs

Drive laboratory efficiency and continuous improvement initiatives (Lean, Six Sigma, digitalization).

Establish and monitor quality KPIs

Promote cost awareness and optimize resource utilization to increase efficiency.

#J-18808-Ljbffr