Pharmaceutical Science Job at Amneal | Apply Now for the Officer – Quality Assurance Role
Start your QA career with a leading pharmaceutical company in Visakhapatnam. This Pharmaceutical Science Job as an Officer – Quality Assurance (IPQA) offers hands-on exposure to API manufacturing, cGMP compliance, in-process checks, and cross-functional quality activities. Ideal for candidates with 2–4 years of API experience looking to grow in a fast-paced, regulated environment.
- Job Post: Officer – Quality Assurance (IPQA)
- Location: Visakhapatnam, Andhra Pradesh, India
- Job ID: 6431
Job Description
The IPQA professional will be responsible for monitoring in-process quality checks in the manufacturing area (API) to ensure compliance with cGMP, SOPs, and regulatory requirements. The role involves real-time verification of manufacturing activities, documentation review, and effective communication with production and QA teams.
Key Responsibilities of the Quality Assurance Job
- Ensure adherence to cGMP and GDP practices during all in-process activities.
- Perform line clearance checks before starting production and packaging operations.
- Monitor and verify critical manufacturing and packaging parameters as per approved BMR/BPR.
- Review and ensure compliance with SOPs, protocols, and regulatory guidelines.
- Verify sampling, labeling, and dispensing of raw materials and intermediates.
- Perform in-process checks and record observations in real-time.
- Ensure timely identification, documentation, and escalation of any deviations, OOS, OOT, or incidents.
- Support QA team in investigations and CAPA implementation.
- Participate in internal audits, regulatory inspections, and compliance activities.
- Maintain effective communication with Production, QC, and QA teams for smooth operations.
- Ensure that all activities are performed safely and in accordance with company policies.
Skills & Competencies
- Strong knowledge of cGMP, GDP, and regulatory compliance.
- Hands-on experience in API manufacturing processes.
- Good understanding of QA/QC procedures.
- Strong communication and interpersonal skills for cross-functional coordination.
- Documentation accuracy and attention to detail.
- Ability to work in a fast-paced manufacturing environment.
Qualifications Required for the Quality Assurance Job
- Qualification: MSc Pharmaceutical Sciences
- Experience: 2 to 4 Years (API industry experience mandatory)
Additional Responsibilities
- Conduct periodic shop floor rounds to ensure compliance with cGMP and safety practices.
- Provide on-the-job training to production personnel on documentation and quality practices.
- Support preparation and review of SOPs, protocols, and batch records.
- Monitor and control environmental conditions in production areas (temperature, pressure differentials, cleanliness).
- Ensure timely closure of deviations, CAPA, and change controls related to IPQA activities.
- Support technology transfer and validation activities from a QA perspective.
- Assist in review of batch manufacturing records (BMR) and batch packaging records (BPR) for completeness and compliance.
- Act as QA representative during regulatory and customer audits.
- Contribute to continuous improvement initiatives in QA and manufacturing processes.
