Manager To Sr. Manager - QC - API Mfg. at Raks Pharma Pvt Ltd Dahej

Role & responsibilities

The position is responsible for supervising in-process and final product quality analyses and laboratory operations in compliance with regulatory requirements and internal quality standards. The role focuses on interpreting and evaluating analytical results to ensure accuracy, precision, and adherence to approved specifications. The role proactively identifies recurring quality issues, prevents potential production and compliance risks, and drives continuous improvement initiatives. The position ensures optimal use of analytical instruments, testing equipment, validated methods, and predefined procedures for acceptance or rejection of materials and products. As a people leader, the role audits and monitors laboratory and manufacturing quality outputs, oversees random testing of finished goods, and ensures timely reporting and resolution of deviations and defects.

Essential Functions:

• Supervise QC laboratory operations and testing activities
• Review and interpret in-process and finished product analytical results
• Ensure compliance with GMP, GLP, and regulatory requirements
• Identify quality trends, risks, and recurring laboratory issues
• Approve or reject materials and products based on analytical outcomes
• Audit and monitor manufacturing and QC processes for compliance
• Review and approve analytical data, COAs, and laboratory documentation
• Lead investigations of deviations, OOS/OOT, and non-conformances
• Drive CAPA effectiveness and continuous improvement initiatives
• Prepare teams for internal, external, and regulatory audits
• Mentor, develop, and manage QC laboratory leadership teams

Additional Responsibilities:

• Responsible for the operation & calibration of balances in Sampling room & to maintain its record.

Preferred candidate profile

Education:

• M. Sc. - Required
• B.Pharm / M. Pharm - Preferred

Experience:

• Minimum 12 years to 18 years experience in Quality Control and Pharmaceuticals company.