Assistant Manager / Deputy Manager

Job Description

Key Responsibilities: Leadership Team Management: Lead and mentor the QC team, ensuring efficient workflow and compliance. Review Approval of Analytical Documents: Oversee Analytical Reports, COAs, Method Validations, and Instrument Calibration Records. Analytical Expertise: Extensive experience in Wet Chemical Analysis, Instrumental Techniques (HPLC, GC, FTIR, UV, Auto Titration, Particle Size Analysis, etc.). Quality System Management: Handle Out of Specification (OOS), Out of Trend (OOT), Deviation Investigations, CAPA Implementation. Regulatory Compliance: Ensure adherence to GMP, GLP, ICH, WHO, FDA, and EU-GMP guidelines. Preparation of SOPs, Specifications, and STPs: Develop and maintain robust quality control procedures. Handling QMS Documents: Oversee Change Control, Market Complaints, Incidents, and Laboratory Investigations. Audit Readiness Compliance: Provide responses and corrective actions for regulatory audits (USFDA, WHO, EU-GMP, MHRA, etc.). Cross-Functional Collaboration: Work closely with Production, RD, and Quality Assurance teams to drive continuous improvements. Required Skills: Strong leadership problem-solving skills. Expertise in API Quality Control, including chemical and instrumental analysis. Proficiency in Regulatory Compliance QMS Documentation. Excellent communication team management capabilities. Hands-on experience in CAPA, Deviation Management, and Analytical Method Validations. Exposure to handling regulatory inspections audit preparations.