Looking for a rewarding Quality Assurance job in the pharmaceutical industry?
An excellent opportunity is open in Visakhapatnam, Andhra Pradesh, for experienced professionals passionate about API manufacturing, cGMP, and regulatory compliance.
This Officer – Quality Assurance position offers hands-on exposure to in-process quality checks, batch documentation, and audit readiness in a top-tier API facility.
Key Responsibilities
- Ensure strict compliance with cGMP and GDP during all in-process manufacturing activities.
- Perform line clearance checks before production and packaging operations.
- Monitor and verify critical manufacturing parameters as per approved BMR/BPR.
- Review SOPs, protocols, and ensure regulatory adherence.
- Oversee sampling, labeling, and dispensing of raw materials and intermediates.
- Conduct in-process checks and record real-time observations.
- Identify, document, and escalate any deviations, OOS, or OOT incidents promptly.
- Support investigations, CAPA, and participate in internal and external audits.
- Facilitate communication with Production, QC, and QA teams for smooth plant operations.
- Ensure all activities comply with safety and company policies.
Additional Responsibilities
- Conduct periodic shop floor rounds to ensure compliance and safety.
- Train production staff on quality documentation practices.
- Support preparation and review of SOPs, BMRs, and BPRs.
- Monitor environmental controls such as temperature and differential pressure.
- Support technology transfer and validation activities from a QA standpoint.
- Act as QA representative during regulatory and customer audits.
- Contribute to continuous improvement initiatives in manufacturing and QA.
Qualifications & Experience
- Qualification: M.Sc. in Chemistry or Pharmaceutical Sciences
- Experience: 1 to 4 years in API manufacturing quality assurance (mandatory)
- Skills:
- Strong knowledge of cGMP, GDP, and quality systems
- Excellent documentation and attention to detail
- Strong interpersonal and communication skills
- Ability to work efficiently in a fast-paced manufacturing environment
Why Join This Role?
- Exposure to world-class API manufacturing processes
- Opportunity to work in cross-functional QA teams
- Active participation in regulatory inspections
- Continuous learning and professional growth in pharma quality systems
