Senior Compliance Officer Job at Pfizer
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
The Sr. Associate, Supplier Quality Compliance will be responsible for ensuring that site standards, policies and procedures are aligned with global Pfizer Quality Standards and regulatory agency’s guidance’s and are operating in a state of compliance. Procure and maintain suppliers and materials used by Rochester by qualification, performing supplier assessment reports and qualification evaluations, monitoring compliance/quality performance of suppliers/materials. Ensure that Rochester remains in an inspection readiness state by conducting internal site systems audits, monitoring compliance/quality performance indicator metrics, performing gap assessments and addressing any areas of non-compliance. Assists in quality areas such as Medical Device & Combination Products (MDCP) audits, investigates product complaints, and generates Annual Product Reviews.
In this role, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams. You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
How You Will Achieve It
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Support departments in the onboarding of vendors/materials
- Collaborate with various sites to performs re-evaluation of Vendors.
- Maintains the Vendor’s Qualification Evaluation
- Communicates change notifications, quality, and compliance issues to User Sites
- Verifies Vendor details and assigns qualification status in Supplier Management System
- Assures Quality Agreement is initiated.
- Assures GMP audit is performed or on audit plan, as applicable.
- Communicates critical issues to Senior Management
- Tracks CAPAs from investigations or audits
- Leads collaboration with impacted sites to develop CAPA for activities that may impact Vendor qualification status.
- Identifies, creates, and assigns status to Supply Channels
- Performs Risk Assessments to assess impact.
- Support regulatory agency/corporate inspections as Supplier Management subject matter expert.
- Attend and present supplier metrics and monthly/quarterly Quality metrics at the Site Quality Review Team Meeting.
- Author and Revise various quality documentation (SOPs, CAS Reports, Change Controls, CAPAs/Commitments, Risk Assessments, Annual Product Reviews and etc.)
- Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.
- Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
- Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Qualifications
- Applicant must have High School Diploma (or Equivalent) with eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.
- Minimum of 2 years related cGMP experience in Quality Operations preferred.
- Prior experience ina GMP quality team environment strongly preferred. The candidate must have demonstrated proficiency in organizational skills, balance multiple priorities, aptitude for technical learning, and problem solving.
- The candidate must have experience in at least several of the following:
- Experience with suppliers/contractors.
- Strong verbal and written communication including presentation skills.
- Has strong technical experience and computer skills with quality systems (change control, deviations, SAP, documentation management, audits, inspections, etc.).
- Demonstrated ability to manage multiple projects and complex suppliers, with strong negotiation skills.
- Able to work and contribute effectively in cross-functional team, culture differences, diversity.
- Familiar with quality auditing.
- Familiar with QC Laboratories, Manufacturing and Packaging Operation
- Knowledgeable with continuous improvements and best industry practices
- Experience with conducting gap assessment and system and process risk assessments.
- Basic understanding of aseptic manufacturing.
- Comprehensive understanding of cGMP guidelines outlined in CFR. Knowledge and demonstrated ability to apply Pfizer Quality Standards to ensure local practices and procedures reflect these requirements.
- Independently writes SOPs, technical reports, validation/qualification documents, project plans, etc.
- Basic understanding of aseptic manufacturing highly desirable.
PHYSICAL/MENTAL REQUIREMENTS
- Must be able to lift a minimum of 30lbs.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Must not have a Penicillin allergy.
- Minimal travel for training/seminars.
- Role will require after hour and weekend support from time to time.
Work Location Assignment: On Premise
Last Date to Apply for Job: May 30, 2023
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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.
EEO & Employment Eligibility
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.
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