Founded in 1849, 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 : MQA Sr. Specialist - Upstream
Job Description
• Review & approval of Master data, Work flows, Master Recipes, Master recipe Configuration documents (MRCD), Business verification (BV) scripts, Signature strategy/Signature Policy documents, and Baseline configuration document (BCD)
• To Provide training on AMPS Master Recipe, Master Workflows, Master Data, EBR review and release to MQ colleagues.
• Responsible for ensuring operating state of cGMP compliance in solution/emulsion preparation, vial/ampoule washing, depyrogenation, filling and capping 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 supervisor.
• Review of batch reports and equipment audit trails. Perform EMS alarm impact assessments and monthly trend reports.
• Ensure start-up and in-process activities performed as per batch record and SOP compliance. Monitor and adherence manufacturing practices with respective standards and approved procedures.
• Perform daily walk throughs and report observations to the supervisors and ensure appropriate closer of those incidents. Perform equipment breakdown assessments w.r.t to product quality and patient safety independently.
• Review and approval of equipment alarms and review of alarm trends. Report any non-compliance to the supervisor. Responsible for performing manufacturing investigations, implementation of CAPAs and to approve investigation and CAPAs.
• Manage investigation and apply relevant and necessary actions/ systems to ensure appropriate closure of those incidents. 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.
• Experience in handling regulatory, corporate and internal auditors / inspectors. Responsible for assisting manufacturing investigators w.r.t collection of data, information and technical support and may perform in conducting investigations.
• Ensure that reports are aligned with regulatory requirements, site standards procedures an company policies. May lead a team of MQA colleagues on an interim basis in the absence of the supervisor.
Candidate Profile
M.Pharm / B.Pharm / M.Sc (Any Specialization)
8 to 10 Years of Experience in Pharmaceutical industry
Additional Information
Experience : 8 to 10 Years
Qualification : B.Pharm / M. Pharm / M.Sc
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance and Control
End Date : 30th October, 2021
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