The MQ TS Downstream Associate ensures compliance to cGMP standards in Terminal Sterilization, Visual Inspection, and Packaging while monitoring processes, conducting inspections, and reporting non-compliance in a pharmaceutical manufacturing setting.
Role Summary:
The MQ TS Downstream Associate 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.
Job 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. Associate or Sr. Team Leader.
Review of Batch reports and Equipment audit trails.
Perform Acceptable Quality level sampling, Inspection in VIDT and Batch record review and release.
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. Associate or Sr. Team Leader.
Review and assessment of equipment alarms and review of quarterly alarm trends.
Report any non-compliance to the Sr. Associate or 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.
Here Is What You Need (Minimum 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 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.
Job 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. Associate or Sr. Team Leader.
Review of Batch reports and Equipment audit trails.
Perform Acceptable Quality level sampling, Inspection in VIDT and Batch record review and release.
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. Associate or Sr. Team Leader.
Review and assessment of equipment alarms and review of quarterly alarm trends.
Report any non-compliance to the Sr. Associate or 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.
Here Is What You Need (Minimum Requirements)
- B. Pharm, M. Pharm, MSc.
- 2-6 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.
- Experience in the pharmaceutical industry and Quality administered systems
- Sound knowledge of current Good Manufacturing Practices (part of GxP)
- Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
- Effective written and oral communication skills.
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
Amp
Cgmp
Ebr
Manufacturing Policies
Quality Assurance Systems
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