QA IPQA Assistant Manager
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Job Summary
Line Clearance: Perform and authorize area/line clearances for dispensing manufacturing and packaging operations to prevent cross-contamination and mix-ups.
Shop Floor Monitoring: Conduct regular rounds to ensure that personnel follow Standard Operating Procedures (SOPs) maintain hygiene and adhere to cleanroom gowning protocols.
In-Process Checks: Execute and supervise physical checks (e.g. weight variation friability disintegration leak tests for blisters) to ensure the product meets specifications during the run.
Sampling: Manage the collection of in-process samples blend samples stability samples and reserve samples according to the sampling plan.
Documentation Review: Real-time review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) to ensure data integrity and online (synchronous) documentation.
Quality Systems & Compliance
Deviation Management: Identify report and initiate investigations for any shop floor incidents or deviations. Support root cause analysis (RCA) and ensure the implementation of CAPA (Corrective and Preventive Actions).
Change Control: Evaluate and review impact assessments for proposed changes in processes equipment or materials.
Validation Support: Monitor process validation cleaning validation and equipment qualification batches ensuring all protocol-defined parameters are recorded accurately.
Audit Readiness: Participate in internal quality audits and maintain the facility in a constant state of readiness for regulatory inspections (e.g. USFDA MHRA WHO).
SOP Preparation: Drafting reviewing and revising departmental SOPs and ensuring all shop floor staff are trained on the latest versions.
Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
