QA/QC - Officer/Executive

Role & responsibilities

To ensure that all in-process manufacturing and packaging activities are carried out as per GMP, SOPs and regulatory requirements. To monitor and control product quality during manufacturing to ensure consistent compliance and documentation integrity.

• In-process monitoring:

  Perform online batch monitoring during manufacturing and packaging stages. Verify critical process parameters and ensure adherence to approved BMR/BPR. Check line clearance before start-up, after breaks, and product changeover. Monitor environmental conditions (temperature, humidity, differential pressure, etc.) during processing. Ensure sampling and testing are done as per SOP (in-process checks, yield, etc.).

• Documentation and Compliance:

  Review and ensure proper entries in BMR/BPR and logbooks. Ensure good documentation practices (GDP) are followed on shop floor. Report and record any deviations, incidents, or non-conformances immediately. Participate in deviation investigations and CAPA implementation.

• Good Manufacturing Practices (GMP):

  Ensure adherence to cGMP and data integrity principles. Support area hygiene, gowning, and material movement compliance. Verify equipment cleaning and status labeling before batch start-up.

• Line Clearance & Batch Release:

  Perform line clearance for manufacturing and packaging operations. Ensure proper reconciliation of materials and labels. Support in batch release after verification of compliance.

• Coordination & Training:

  Coordinate with production, QC, and warehouse for smooth process flow. Assist in qualification, validation, and process audits when required. Participate in internal audits and provide support for regulatory inspections.

Preferred candidate profile

• Knowledge of GMP, GLP, GDP practices.
• Understanding of pharmaceutical manufacturing process.

• Communication and interpersonal skills

  : The candidate should have excellent communication, interpersonal, and people management skills.

• Problem-solving skills

  : The candidate should have practical problem-solving skills and experience with formal problem-solving methodologies.

• Attention to detail

  : The candidate should have excellent attention to detail.

• Leadership skills

  : The candidate should have leadership skills.

• IT proficiency

  : The candidate should be proficient in using basic IT applications like Word, Excel, and Outlook.