Key Responsibilities
- Review executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.
- Assist in review, release of materials, components used in planning and batch manufacturing.
- Prepare and summarize data associate with site metrics ,write, read, and revise technical reports
- Must have QA core experience, and have the ability to train and support staff regarding QA responsibilities as needed
- Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations
- Adhere to all applicable regulations, policies, and procedure for health, safety and environmental compliance.
- Execute the assigned training and development plan.
- Troubleshoot systemic GMP issues
- Provide leadership on projects and within systems that interface with other departments
- Provides SME support, review and approval during meetings, audits, investigations, technical reports, etc.
Key Interactions
INTERNAL STAKEHOLDERS NATURE / PURPOSE OF THE INTERACTION Manufacturing / Operations Inform team of necessary documentation corrections Quality Control Collaboration and problem solving during standard and non-routine events.
Warehouse Relay information related to documentation needed for batch disposition. EXTERNAL STAKEHOLDERS NATURE / PURPOSE OF THE INTERACTION Clients Occasional interaction with clients during visits or tours
Physical Demands
- Ability to wear gowning materials for extended periods of time
- Required to maintain good personal hygiene
- Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected
- Periodic lifting up to pounds
- Long periods of standing and walking
Work Envoirnment
- This job primarily operates in a high demand office and manufacturing setting, periodically works inside the manufacturing core
- Potential limited exposure to hazardous chemicals
- Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing.
As such, all PPS staff work in or nearby either chemical / pharmaceutical research or chemical / pharmaceutical manufacturing equipment and processes.
- Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.
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