Overview
Quality Control Manager Jobs in Nadiad, Gujarat, India at Intracin Pharmaceutical Pvt Ltd
Title: Quality Control Manager
Company: Intracin Pharmaceutical Pvt Ltd
Location: Nadiad, Gujarat, India
Intracin Pharmaceutical Pvt. Ltd. is a WHO-GMP certified pharmaceutical manufacturer specializing in sterile injectable formulations for human and veterinary healthcare. We are committed to delivering high-quality products that comply with national and international regulatory standards.
We are looking for an experienced and result-oriented Quality Control Manager to lead our QC team and ensure the highest standards of analytical testing, compliance, and laboratory excellence.
Key Responsibilities
- Lead and manage the Quality Control department, ensuring compliance with cGMP, GLP, WHO-GMP, and applicable regulatory requirements.
- Review and approve analytical reports, Certificates of Analysis (COA), specifications, SOPs, protocols, and laboratory investigations.
- Oversee testing of raw materials, packaging materials, in-process samples, finished products, purified water, and stability samples.
- Ensure timely release of materials and finished products through effective laboratory operations.
- Supervise analytical activities using HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Apparatus, TOC Analyzer, and other laboratory instruments.
- Ensure proper calibration, qualification, preventive maintenance, and validation of laboratory equipment.
- Review and investigate OOS (Out of Specification), OOT (Out of Trend), deviations, laboratory incidents, and implement CAPA.
- Manage analytical method validation, method transfer, verification, and cleaning validation studies.
- Coordinate stability studies as per ICH guidelines and maintain stability program documentation.
- Ensure compliance with Data Integrity (ALCOA+) principles and maintain laboratory documentation.
- Prepare the QC department for regulatory inspections and customer audits, including WHO, PIC/S, and international regulatory authorities.
- Review laboratory trends and implement continuous improvement initiatives.
- Train, mentor, and develop QC analysts and laboratory personnel.
- Coordinate effectively with QA, Production, Warehouse, Regulatory Affairs, and R&D departments.
Qualification
- M.Sc. (Chemistry/Analytical Chemistry) or M.Pharm (Quality Assurance/Pharmaceutical Analysis) or B.Pharm with relevant experience.
Experience
- 7-8 years of experience in pharmaceutical Quality Control.
- Minimum 3 years of experience in a managerial or leadership role.
- Experience in sterile injectable manufacturing will be highly preferred.
Required Technical Skills
- Strong knowledge of cGMP, GLP, WHO-GMP, Schedule M, ICH, IP, BP, USP, and pharmacopoeial requirements.
- Hands-on experience with HPLC, GC, UV, FTIR, Dissolution, Karl Fischer, and other analytical instruments.
- Expertise in analytical method validation and transfer.
- Experience in OOS, OOT, deviation investigations, CAPA, and change control,Stability Studies
- Good understanding of laboratory software, LIMS, and Data Integrity requirements.
- Experience handling regulatory and customer audits is preferred.
Key Competencies
- Leadership and team management
- Analytical and problem-solving skills
- Decision-making ability
- Effective communication and interpersonal skills
- Attention to detail
- Time management and planning
- Regulatory compliance mindset
