Group Manager- Chemical Quality
1 month ago
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
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
Manage multiple projects and ongoing work activities of moderate complexity within the division typically involving cross-functional representatives. Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management. Review and approve documentation associated with Good Manufacturing Practices {also cGMP}, method validation, investigation of change controls and technical reports. Collaborate with site functional areas and customers to support site goals, objectives and timelines. Ensure alignment to all regulations and Pfizer Quality Standards related to area of oversight and work with other management teams to ensure support for all testing activities in the routine testing area. Provide oversight of Microbiology product testing group responsible for routine testing of product or process samples for endotoxin and bioburden. Oversee project management of all Data Integrity related activities with the relevant teams. Address and resolve any potential issues with regulatory impact. Develop and maintain alignment with current industry best practice related to cleanroom techniques and share with the respective teams. Represent area of responsibility at meetings and in audits. Provide information, discuss problem batches, manufacturing/technical issues, deviations and other events with potential impact on product quality and/or supply. Foster teamwork and colleague development, as well as change management, within the department and set up departmental metrics to achieve operation effectiveness.
Qualifications
Must-Have
Bachelor's Degree in Pharmacy or Masters in Chemistry/ Pharmacy 12+ years' experience 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 Reasoning ability including strong analytical and problem solving abilities Strong people management experience Strong verbal and written communication skills
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.
Nice-to-Have
Master's degree Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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