TI
Job Description
Key Responsibilities:
In-Process (IP) Responsibilities:
- Perform line clearance and IP checks during manufacturing and packaging activities.
- Monitor critical process parameters during granulation, compression, coating, filling, and packing.
- Verify BMR/BPR entries and ensure Good Documentation Practices (GDP).
- Collect and test in-process samples as per approved specifications.
- Report and escalate any deviations, non-conformities, or abnormal observations.
Finished Product (FP) Responsibilities:
- Sample and submit finished product batches for QC testing.
- Coordinate with the QC department for timely testing and release of finished goods.
- Ensure FP storage conditions and labeling are as per SOPs.
- Assist in reviewing batch records and supporting batch release activities.
- Coordinate with warehousing for approved and rejected batch segregation.
Qualifications:
- B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, or relevant field.
- 1–3 years of experience in QA or QC, preferably in formulations or oral solid dosage manufacturing.
Key Skills:
- Good understanding of cGMP, GDP, and regulatory compliance (USFDA, WHO, MHRA, etc.).
- Knowledge of production processes and quality checkpoints.
- Strong documentation, observation, and communication skills.
- Familiarity with QMS tools like deviation, change control, and CAPA (optional but preferred).
- Ability to work in shifts and in a fast-paced environment.