Senior Quality Operations Technical Specialist
Senior Quality Operations Technical Specialist
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Provides Quality Unit support and guidance to the Memphis Logistics Center. Assist in the design, implementation, performance and monitoring of GMP/GDP Quality Systems and of compliance related initiatives within the Memphis Logistics and Supply Network. This position functions as the subject matter expert for all GMP/GDP quality, compliance and regulatory issues for the US Logistic Center Network and is the key contact for regulatory inspections and GMP/GDP audits within the LCs.
Performs a critical role in championing quality/compliance systems, facilities, equipments, processes, and culture.
•Partners with MLC Operations Management to continually improve the operations
•Provides Subject Matter expertise on all Quality/Compliance related matters to the LCs.
•Ensures quality and compliance requirements are incorporated into MLC Operations and business plans.
Manage GMP related investigations and conduct quality portion of the investigations as appropriate. Actions include:
•Accountable for management of the investigation tracking tool
•Initiate & assign investigations (QARs)
•Partner with SME/Process Owner to conduct investigation and document investigation reports
•Ensure comprehensive Investigation Reports are completed including accurate Root Cause and appropriate CAPA
•Tracks and Follow-up on open investigations. Drives open issues to closure
•Trend Investigations to identify opportunities for continuous improvement
•Compiles and analyzes Investigation related data and calculates performance metrics for presentation to site Management
Manages the Internal Self Assessment program and the External Supplier/Service Provider Audit program
•Perform routine internal assessments of MLC Operations and Quality Systems to assess compliance to Standard Operating Procedures and GMP/PQS requirements
•Perform periodic audits of GMP/GDP related Suppliers/Service Providers to assess compliance with GMSs/GDPs/Quality Agreements, etc. Develop Annual Plan(s) based upon risk factors
•Preparing assessment/audit agendas and coordinating with Process Owner/SME
•Coordinating date and time of audits with applicable Process Owner/SME/Supplier/Service Provider
•Conducting the assessments/audits
•Preparing and publishing the assessment reports
•Work with site Management to determine the appropriateness of the responses to the gaps/observations
•Performing follow-up activities on the assessments/audits to ensure items are properly completed in a timely basis
Manages the Commitment Tracking Program in the MLC
•Accountable for management of the Commitment Tracking Spreadsheet/Monitoring Tool
•Tracks Commitments and works with Commitment Owner to drive closure and prevent from going overdue
•Trends Commitments to identify opportunities for improvement and performance of the Commitment Systems
•Compiles and analyzes Commitment related data and calculates performance metrics for presentation to site Management
Supervises the SOP Lifecycle Process to ensure compliance with regulations and Pfizer Quality Standards
•Works with SMEs/Process Owners to conduct PQS=>CAS=>SOP mapping to ensure MLC SOPs/Job Aids are compliant with corporate GMP requirements
•Partners with SMEs/Process Owners to write SOPs and Job Aids (JAs) to ensure compliance with PQSs and to support the MLC operation.
•Provide quality consultation on SOPs and JAs for other departments.
Manage and control material status within the distribution network. This includes:
•Ensure the material status of product that is listed on a Quarantine Alert Notice is properly changed and product is withheld from distribution until final disposition is obtained Review documentation for products received at MLC to support various requirements and release within SAP
•Evaluate product Shipping Temperature Excursions and provide disposition decisions
•Review and approve documentation for products being shipped to the Memphis Logistics Center under quarantine.
•Responsible for identifying and quarantining materials involved in deviation investigations
•Evaluate product returns and provide disposition instructions.
•Evaluate damaged product and provide disposition instructions
Responsible for performing other activities and special projects as assigned to ensure quality, compliance and continuous improvement. Examples include:
•Provide Quality support to NALO initiatives as needed (e.g. Quality Agreements, Market Actions, Licensure Activities, etc.)
•Develop and conduct annual GMP Training
•Support activities during site regulatory visits
Bachelors of Science Degree in a technical/scientific field (preferably Chemistry, Biology, Engineering, etc.). Advanced degree in a scientific field is strongly preferred.
•Minimum of 5 years experience in a Pharmaceutical GMP related manufacturing and/or laboratory environment
•Significant experience conducting investigations and writing reports
•Conducting audits and hosting inspections
•Writing SOPs/Job Aids
•SAP Experience preferred
TECHNICAL SKILLS REQUIREMENTS
•Working Knowledge GMP and GDP regulations
•Familiarity with USP requirements
•Technical writing skills
•Communication skills across diverse functional groups and layers of management
•Collaboration, Partnership, and Interpersonal Skills
Equal Employment Opportunity
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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