Job Description

You will be a member of Pfizer s dedicated and highly effective quality assurance and control team You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients Your understanding of Quality Control (QC) instruments will help us meet their accuracy specifications against established standards You will also be relied on for setting requirements for the transfer of methodology from Research and Development (R&D) As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements Your risk-taking ability will help us advance new concepts and methodologies You will provide technical guidance and oversight to team members and help in problem solving It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe How You Will Achieve It Coordination with Global Sites as part of Analytical Tech.Transfer activities. Attending Global Regulatory Tech.Transfer meetings for supporting deliverables. Attending New product introduction meetings. Attending Regulatory Peer review for supporting Regulatory submissions. Attending PV & TT Readiness for Product Launches Attending Alternative Vendor development meetings. Attending Change control board meetings. Monitoring of regular analytical activities related to Analytical technology transfer activities. Pharmacopeial Compendial Compliance. Elemental Impurities QRMs approval for the drug products as per the ICHQ3D & USP guidelines and related Method development and method validations. Alternative method development, method validations and Method equivalencies. Mitigating the method lifecycle issues and periodic review. Approval of all Protocols, Summary Reports and Training presentations. Providing required SOP and Protocol trainings. Handling of internal and external audits. Support for on time closure of RAAC /LIR / Incidents / CAPA. Ensuring the Personnel safety in the Quality Control, Safe handling of Laboratory Glassware. Addressing internal/global/ regulatory audit comments. Providing impact assessment for cross functional Change controls. Approval of Specifications, Standard testing procedures, GTP and record of analysis. Evaluate the PQS changes applicability to site procedures and requirement of CAS report preparation. Escalation of analytical issues to next level People Management Engage and inspire the team on performance expectations and coach the team to meet those expectations using Coaching Skill principles. Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics. Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach the team. Be accountable for the Good Data Management and Data integrity understanding and performance of the team. Effectively monitor the actions of the team. Ensure an active daily presence in the GMP work area to observe the work activity and practices. Note: any compliance deviations noted must be investigated in accordance with Site Standard Operating Procedures. Be available to the direct reports for real time escalations of any concerns or support needs Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity. Lead and support continuous improvement efforts, where applicable. Be a role model to support a positive compliance culture. Review the content of all Leader Led Conversations and, on an annual basis, conduct two Leader Led Conversations with the teams aimed at fostering a culture that supports compliance with procedures, including good data management. Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles. Qualifications Must-Have Bachelors/ Masters Degree in Pharmacy/ Sciences 10+ years of relevant pharmaceutical industry experience Demonstrates technical/functional expertise in applicable discipline and acquires knowledge in related disciplines. Demonstrated experience in Quality Control Extensive knowledge of Good Manufacturing Practices also cGMP compliance requirements for Quality Control Laboratories, application of compendial methods and experience with a wide range of analytical techniques In-depth understanding of aseptic processing and monitoring procedures Reasoning ability including strong analytical and problem solving abilities Strong people management experience Strong verbal and written communication skills Nice-to-Have Masters degree Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.

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