We are looking for an experienced Sr. Executive – QC (QMS) to ensure effective implementation and compliance of Quality Management Systems, regulatory requirements, documentation, audits, validation and quality processes within the organization.
Key Responsibilities
- Ensure compliance with QMS, GMP, GLP and WHO-GMP requirements.
- Prepare, review and maintain QMS documentation and regulatory dossiers.
- Ensure ALCOA+ principles are followed in all quality-related documentation and records.
- Handle deviations, investigations, Root Cause Analysis (RCA) and CAPA.
- Conduct and support internal audits and regulatory inspections.
- Manage calibration activities and related documentation.
- Handle Analytical Method Validation (AMV) and other validation activities.
- Prepare and review APQR/PQR documentation.
- Support food safety and quality compliance requirements.
- Handle product recall procedures and related documentation.
- Ensure proper documentation, data integrity and compliance with applicable quality standards.
- Coordinate with QC, R&D;, Production and other departments for QMS-related activities.
- HPLC
- UV-Vis Spectrophotometer
- KF Titrator
- IR
Soft Skills:
- Good Communication Skills
- Leadership Skills
- Teamwork
- Problem-Solving Skills
- Robust Documentation Skills
Mandatory Requirements
- Strong knowledge of ALCOA+ and QMS Documentation
- Experience in Internal Audits
- Hands-on experience in Analytical Method Validation (AMV)
- Practical knowledge of GMP/GLP compliance
- Experience in handling Deviations, RCA and CAPA
Preferred Qualifications
- Experience in Regulatory Inspections
- Knowledge of APQR/PQR
- Experience in Pharmaceutical or Food Industry
Educational Qualification
B.Pharm / M.Pharm / M.Sc. from a recognized institution.
Industry Preference
Pharmaceutical / Food Industry
Experience
4–8 years of relevant experience in QMS/QA/QC, preferably in the Pharmaceutical or Food industry.