The Associate Manager ensures compliance with cGMP standards in Terminal Sterilization, Visual Inspection, and Packaging operations, reviewing batch reports and addressing non-compliance issues.
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)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
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.
Quality Assurance and Control
Top Skills
Acceptable Quality Level Sampling
Amp Exceptions
Cgmp Standards
Ebr
Equipment Audit Trails
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