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 R&D 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.
Why Join Us
Leadership role in a fast-growing pharmaceutical company.
Competitive salary & benefits package.
Opportunity to work on cutting-edge API analytical projects.
Exposure to global regulatory standards and audits.
leadership,team management,quality system management,compliance,regulatory compliance,qms documentation,audit readiness,capa,market complaints,wet & chemical analysis,analytical method validations,instrumental,deviation management,instrumental techniques (hplc, gc, ftir, uv, auto titration, particle size analysis),quality control,cross-functional collaboration,change control