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.