Senior QC+QA Trainer(Lab Experience Required)

7 days ago

Kolkatta, India Tek Support Full time

Job Title: Senior QC + QA Trainer (Pharma / Biotech Laboratory) Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced and knowledgeable QC + QA Trainer to design, develop, and deliver technical training programs for quality control and quality assurance teams. The trainer will be responsible for building competence in analytical testing, documentation practices, GMP compliance, and QA/QC systems within a regulated laboratory environment. Key Responsibilities: Training & Development Develop and deliver structured training programs on QC laboratory techniques, QA systems, and GMP compliance . Conduct practical laboratory training (analytical instruments, wet chemistry, microbiology as applicable). Train teams on Good Documentation Practices (GDP), Data Integrity (DI), and OOS/OOT handling . Prepare and update SOP-based training modules and competency assessments . Conduct refresher training, audits-based retraining, and new hire onboarding sessions . Technical & Quality Expertise Provide hands-on training in HPLC, GC, UV-Vis, FTIR, Dissolution, Wet Chemistry , and analytical data review . Guide QA and QC personnel on Change Control, Deviation, CAPA, and Internal Audits . Ensure all training programs align with cGMP, GLP, ISO, and regulatory (USFDA, MHRA, WHO) guidelines . Support QA in documentation review, batch record review, and laboratory compliance . Training System Management Maintain training matrices , records, and competency evaluation logs. Collaborate with QA Training/HR teams for periodic training plan updates. Perform gap assessments and recommend improvement actions. Participate in regulatory inspection readiness and training audits . Education: M.Sc. / B.Pharm / M.Pharm / B.Sc. in Chemistry, Biochemistry, Microbiology, or related discipline. Experience: Minimum 10–15 years total experience in QC and QA within the pharmaceutical/biotech/FMCG domain. Minimum 5 years of direct laboratory experience (analytical or microbiology lab). Prior training, mentoring, or internal trainer experience is preferred. Technical Competencies: Strong knowledge of GMP, GLP, GDP, Data Integrity, QMS . Expert in analytical method validation, calibration, and documentation . Familiar with regulatory inspection observations (FDA, EU, WHO, MHRA) . Proficient in root cause analysis, deviation management, CAPA systems . Soft Skills: Excellent communication and presentation skills. Strong documentation and report-writing skills. Ability to coach and mentor multi-level teams. Proactive, detail-oriented, and organized approach to training delivery.

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