Pfizer is the world's 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 : Senior Specialist - QA Inspection Readiness
Job Description
• Proven experience in handling/management of regulatory inspections like USFDA, Health Canada and EU.
• Thorough knowledge on pharmaceutical regulations/guidelines and Good Manufacturing Practices.
• Performing gap assessments against regulatory guidance's/ network assessments and development of action plan for the same.
• Follow-up on corrective actions/preventive actions derived from regulatory inspections and third party or corporate assessments.
• Preparation of the governance meeting presentations to present in site meetings and leadership meetings.
• Responsible for scheduling governance meetings and notify any delays in actions to the management.
• Experience in back room and front room preparation for regulatory inspections.
• Collect and coordinate data for opening meeting presentation for Inspections or Assessments.
• Preparation of regulatory inspection, assessments data for site Quality metrics.
• Scheduling and conducting facility walkthroughs to ensure compliance.
• Ability to write well-structured technical reports.
• Participates and contributes as a team member and takes responsibility of the Inspection readiness teams milestones/ deliverables.
Candidate Profile
M.Sc./ M. Pharm with 7 years of experience in pharmaceutical industry, preferably in sterile formulations.
Additional Information
Experience : 7 years
Qualification : M.Sc./ M.Pharm
Location : Vizag
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : QA Inspection Readiness
End Date : 10th May, 2020
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