Role Summary

The MQ TS 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.

Responsibilities

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

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.

Report any non-compliance to the Sr. Team Leader

Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.

Identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime, and increase the Efficiency. AMPS Recipe review and validation of recipe.

Experience in handling regulatory, corporate and internal auditors/ inspectors

Here Is What You Need (Minimum Requirements)

Candidate must have B. Pharm, M. Pharm, MSc. with 6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.

Bonus Points If You Have (Preferred Requirements)

Experience in quality administered systems

Strong organizational skills and attention to detail

Experience with regulatory compliance and documentation

Ability to mentor and review the work of other colleagues

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.