Manager Quality Operations
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 team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
It is your problem solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.
This position is responsible for Quality Operations (QO) Tech Transfer support within the PGS-Kalamazoo site including technical project implementation and providing Single Point of Contact (SPOC) for QO support and system implementation. Projects include plant network strategy transfers, new product implementation in Co-development with Research & Development, and internal Continuous Improvement and Organic Growth.
Familiarity with GMP requirements and industry quality assurance practices and systems. With guidance, coordinate and implement the quality systems integration of a variety of projects, which includes working in the following areas of QO:
Analytical Method Transfer Exercise (AMTE) Support -- Coordinates bringing new analytical methods into the release labs to support the introduction of new products to the site, with a focus on:
1) Analytical technology capability assessments
2) AMTE protocol and report authoring
3) Test Plan creation
CMC-Site Compliance - Preparing the site regulatory submission strategy with key objectives related to:
1) Regulatory strategy development
2) Interaction with health authorities including preparation of PAI activities
3) Process Change Form (PCF) authoring to support new product submissions
4) Maintain knowledge of product filing to support inquiry responses from internal and external customers
5) Participates in internal GMP audits and supports customer and regulatory audits, as needed.
QA Floor Support – Integrates new products in the site quality systems. Conducts and reviews non-conformance investigations related to the manufacturing, packaging, testing of product, sterility assurance, and all other cGMP functions. Provides guidance and oversight in identifying root cause and preventative corrective action. Leads and reviews formal risk assessments. Releases materials related to project activities. Activities include:
1) Strategy development and implementation
2) Lot Release
3) Deviation management
4) Change Control Management
QA Validation Support– Reviews and may help develop product and process validation strategies. Work with the project team to assure global validation strategies are executed with respect to:
1) Process Validation
2) Equipment Validation
3) Cleaning validation
Raw / packaging material Support – Supports the data gathering, evaluation and release of raw materials, packaging, and Pfizer produced products that conform to corporate, customer, and regulatory standards, with an emphasis on:
1) New raw material assessment
2) Test plan maintenance
2) Lot Release
Bachelor’s degree in Chemistry, Biochemistry, Microbiology or related science and at least 6 years of relevant experience in pharmaceutical quality operations required. Candidates with related advanced science degrees and relevant experience may also be considered as follows: Master’s degree with at least 4 years experience or PhD with at least 2 years experience.
Experience in a cGMP environment, with a strong working knowledge of a variety of pharmaceutical quality systems and processes including analytical testing, method transfer, deviation investigation, raw and packaging materials, lot release, manufacturing support, process validation, site compliance and project management related to active pharmaceutical ingredients, liquid / semi solids, injectable products and/or vaccines.
Demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.
At least 5 years experience working in pharmaceutical product transfers
Experience in active pharmaceutical product or drug product lot release activities
Work primarily performed in an office environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position may require occasional travel, dependent on project needs.
- Last Date to Apply: August 9, 2021
- Eligible for Relocation Package