Assistant Manager Qc

Job Description:

Job Description:

We are hiring an experienced QC professional to lead and manage quality control operations in our API manufacturing unit. The Assistant Manager will be responsible for supervising analytical activities, ensuring regulatory compliance, handling audits, and supporting continuous improvement initiatives.

Key Responsibilities:

• Supervise routine analysis of raw materials, intermediates, and finished APIs

• Review and approve analytical documents (STP, SOPs, COAs, protocols, etc.)

• Ensure compliance with cGMP, ICH, and regulatory guidelines (USFDA, WHO, EU GMP)

• Manage HPLC, GC, UV, FTIR, and other analytical instruments

• Lead investigations of OOS, OOT, deviations, and lab incidents

• Oversee method validation, calibration, and stability studies

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

• Train and mentor QC analysts and junior staff

• Prepare for and participate in regulatory and customer audits

• Maintain lab data integrity and ensure adherence to ALCOA+ principles

Key Skills & Competencies:

• In-depth knowledge of analytical techniques (HPLC, GC, etc.)

• Strong understanding of cGMP and global regulatory requirements

• Experience in API industry QC operations

• Proficiency in data review and laboratory documentation

• Team leadership and cross-functional coordination

• Exposure to software like LIMS, Empower, or Chromeleon is a plus