We are hiring for the Quality Assurance department from the API manufacturing industry experience only .

Officer / Executive

Experience in Quality Assurance API industry.

Key skills: IPQA & AQA

AQA Job roles :

- Review analytical data, test reports, calculations, and laboratory records.
- Ensure compliance with GMP, GLP, regulatory requirements, and approved procedures.
- Review and approve specifications, analytical methods, protocols, and standard operating procedures.
- Investigate deviations, out-of-specification (OOS), out-of-trend (OOT), and atypical results.
- Review method validation, verification, transfer, and stability-study documentation.
- Ensure data integrity and compliance with ALCOA+ principles.
- Perform audit-trail reviews of laboratory systems and instruments.
- Support CAPA, change controls, risk assessments, and laboratory investigations.
- Monitor calibration, qualification, and preventive maintenance of analytical instruments.

IPQA Job roles :

- Perform line clearance before manufacturing and packaging activities.
- Monitor shop-floor operations for compliance with GMP, SOPs, and approved batch records.
- Verify dispensing, equipment status, material identity, and process parameters.




- Conduct in-process checks, sampling, and reconciliation.
- Review batch manufacturing and packaging records in real time.
- Ensure proper documentation and adherence to data-integrity requirements.
- Identify and report deviations, non-conformances, and process discrepancies.
- Support deviation investigations, CAPA, change controls, and risk assessments.
- Verify equipment cleaning, area cleanliness, environmental conditions, and status labels.
- Monitor hold times and adherence to validated processes.
- Coordinate the handling of rejected, returned, or quarantined materials.
- Participate in process validation, cleaning validation, and qualification activities.
- Support internal, customer, and regulatory audits.
- Coordinate with Production, Quality Control, Warehouse, Engineering, and other departments.
- Ensure batches are released for subsequent processing only after meeting defined requirements.

MSc in Chemistry with 2 to 5 years, API Industry experience only.

Note : Only male candidates to apply as it will be 24/7 Shift . operating setting.

📌 Quality Assurance officer (API industry) (Bengaluru)
🏢 Hikal
📍 Bengaluru