Founded in 1849, Pfizer is the worlds premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Executive - Quality Assurance
Job Description
• Fundamental knowledge on manufacturing and Quality control activities, such as Solution preparation, filling, terminal sterilization, visual inspection, packing, in process sampling and analysis.
• Knowledge in change control assessment
• Responsible for review and approval of equipment qualifications, equipment audit trails and instruments qualifications associated with computers systems.
• Effective communication with all staff from different levels and builds constructive and effective relationship
• Review of product & process related SOP & Forms
• Should have trouble shooting abilities in manufacturing & quality control area, which helps the organization to develop, implement and achieve its mission, vision and values
• Report any non-compliance to the Supervisor
• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Create, review and approve Good Manufacturing Practices {also cGMP} audit reports.
• Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
• Create, review and approve deviations and consistently produce quality work.
• Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact.
• Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
• Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
• Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
• Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.
• Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.
Candidate Profile
• Degree in B.Pharm/M.Pharm/M.Sc
• Experience in pharmaceutical industry: 4 – 6 years of experience in Quality Assurance / Quality control of sterile dosage manufacturing facility.
• Experience in Quality administered systems
• Sound knowledge of current Good Manufacturing Practices {part of GxP}
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills
• Experience at a manufacturing site
• Experience of writing and managing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
Additional Information
Qualification : B.Pharma / M.Pharma / M.Sc
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QA
End Date : 20th July, 2021
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