QC Manager

Job Description:

Job Title: QC Manager

Company: Concept Pharmaceuticals Ltd.
Location: Aurangabad
Experience: 8–10 Years
Salary Range: ₹Negotiable

Job Summary

We are looking for an experienced Quality Control (QC) Manager to lead and manage the Quality Control function at our pharmaceutical manufacturing facility. The role involves ensuring compliance with regulatory standards, managing laboratory operations, and maintaining high quality standards across raw materials, in-process, and finished products.

Key Responsibilities

• Lead and manage the Quality Control department including analysts, executives, and lab staff

• Ensure compliance with cGMP, GLP, WHO-GMP, and regulatory requirements

• Review and approve analytical results for raw materials, intermediates, finished products, and stability samples

• Ensure timely testing, documentation, and release of materials and products

• Handle OOS, OOT, deviations, CAPA, and investigation reports

• Review and approve SOPs, STPs, protocols, validation reports, and COAs

• Coordinate with QA, Production, and Regulatory teams for smooth operations

• Manage and prepare for regulatory audits and inspections (WHO, FDA, DCGI, customer audits)

• Ensure calibration, qualification, and maintenance of QC instruments

• Monitor laboratory compliance, data integrity, and documentation practices

• Support method validation, method transfer, and stability studies

• Train, mentor, and evaluate QC team members

Required Skills & Competencies

• Strong knowledge of pharmaceutical QC systems and analytical techniques

• Hands-on experience with instruments like HPLC, GC, UV, FTIR, Dissolution, etc.

• Sound understanding of regulatory guidelines and audit handling

• Excellent documentation, analytical, and problem-solving skills

• Leadership and team management capabilities

• Good communication and cross-functional coordination skills

Educational Qualification

• M.Sc. (Chemistry / Pharmaceutical Chemistry / Analytical Chemistry)
  or

• B.Pharm / M.Pharm (preferred)

Preferred Candidate Profile

• Experience in a regulated pharmaceutical manufacturing environment

• Exposure to regulatory audits and compliance management

• Stable career history with leadership exposure in QC