Quality Control Manager - Injectables

Role Overview

The Quality Control Manager will oversee all QC activities related to injectable pharmaceutical products, covering raw materials, packaging materials, in-process, finished products, and stability testing phases. The position demands thorough review and validation of analytical data and quality control documentation, managing non-conformance events such as OOS (Out of Specification), OOT (Out of Trend), and deviations, along with handling CAPA and investigations to maintain quality standards.

Responsibilities

• Supervise QC testing for injectable drugs at various stages including raw, in-process, finished, and stability samples.
• Review analytical outcomes and ensure accuracy and compliance in QC documentation.
• Manage and resolve issues like OOS, OOT, deviations, CAPA, and related investigations effectively.
• Monitor and ensure adherence to GMP, GLP, and regulatory standards.
• Coordinate the calibration and qualification of QC instruments to guarantee precise testing.
• Collaborate with QA and Production teams to facilitate batch release processes.
• Lead and manage the QC team, ensuring prompt completion of testing and documentation.
• Support quality audits and contribute to closing observations raised during inspections.

Candidate Requirements

• Possess a Bachelor's degree in Chemistry (B.Sc) or Pharmacy (B.Pharma) in any specialization.

Additional Information

The candidate will be responsible for upholding the integrity and consistency of quality control processes in line with strict pharmaceutical manufacturing standards. Effective teamwork and leadership skills are essential for managing the QC team and coordinating with multiple departments.