Job Summary: Quality inspection of pharmaceutical manufacturing and documents.Quality inspection of pharmaceutical manufacturing and documents.
1.0 QA Activities in Production:
1.1 To implement approved departmental SOPs.
1.2 To give line clearance for the production activities in the production area.
1.3 Sampling of finished products, intermediates, In-process, stability samples, cleaning validation & verification samples and reserve samples.
1.4 To approve packaging materials specimen to be attached with POIs.
1.5 To check manufacturing and packaging POIs in the production area.
1.6 Checking of finished goods and release (for dispatch)/rejection by authorize person.
1.7 Affixing Release and Rejection labels submitted by QC for product batches at different stages of manufacturing.
1.8 To highlight quality related problems for proper investigation.
1.9 Follow the documentation system requirements.
1.10 Activities related to control of non-conforming products such as rejection for investigation, rejection for destruction, out of specification etc.
1.11 Follow up of compliance with cGMP in production department “Conduct cGMP check rounds in production”.
1.12 Training Needs
1.12.1 Training on related QA standard operating procedures.
1.12.2 Training courses (technical) to increase the professional abilities and skills.
1.12.3 Specific training needs are stated in the ‘Job title training needs list’.
2.0 QA Activities in Warehouse:
2.1 Conduct cGMP check rounds in warehouse
2.2 Checking and approving Tender and Registration samples.
2.3 Issuing APPROVED labels for loose packaging materials issued from warehouse to production department.
2.4 Management of Rejected Materials by following all relevant procedures which includes destruction of rejected materials by incineration or disposal of rejected materials to external parties for destruction.
3.0 Any other job assigned by the direct supervisor or department manager.
Required Skills:
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