MQA Downstream Associate Manager @ Pfizer

Job Description

The MQA Downstream Associate Manager is responsible for primary contact of quality on the floor, Particularly in the Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards.

Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.

Responsibilities:

MES quality operationss

Maintain regulatory compliance in accordance with cGMP practices

Ensure manufacturing policies and procedures conform to Pfizer standards

Knowledge and hands on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Team leader.

Review of Batch reports, and Equipment audit trails.

Perform Acceptable Quality level sampling, Inspection and record the results in Batch records for all products

Perform batch start-up and end activities viz. sensor challenge tests, recipe review etc.

Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging.

Perform Daily walkthroughs and report observations to the Sr. Team leader.

Perform Equipment breakdown assessments w.r.t to Product Quality and patient safety with technical support/inputs from Sr. Team Leader.

Review and assessment of equipment alarms and review of quarterly alarm trends.

Experience:

B. Pharm, M. Pharm, MSc.

6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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Keyskills:   Visual Inspection Downstream Terminal Sterilization Shop Floor Packaging operations AMP Batch records cGMP MQA