4 days old

Compliance Specialist

Pfizer
Franklin, OH 45005
**ROLE SUMMARY:**

Responsible for Quality Compliance with Pfizer Quality Standards (PQS), cGMP Regulatory Guidelines, Internal and External Audit Commitments of manufacturing and laboratory facilities, Validation and Qualification System, ALCOA/data integrity program, project improvement and corrective actions are completed within specified time frames. Identify, support, and drive initiatives that support local quality compliance programs.



**ROLE RESPONSIBILITIES:**



+ Accountable for adhering to Pfizer standards, guidelines and values

+ Identifies and implements processes to improve performance and increase efficiency, (consciously balancing the risk and reward trade-off)

+ Work is performed under broad guidelines and with limited supervision

+ Perform a variety of Validation activities in compliance with Good Manufacturing Practices (GMP) and Validation Master Plan (VMP) requirements

+ Document Editing/Verification/Review and approval of official documents

+ Manage simultaneous projects; retrieve, analyze, summarize and tabulate data for informed reporting to upper management; update trackers and project progress reports

+ Liaison/management activities with Corporate Validation or other entities including consultants



**BASIC QUALIFICATIONS**



+ BS, or MS in related science or engineering

+ Minimum of 5 years of Experience in Pharmaceutical or Medical device industries

+ **Language Skills:** Must be proficient in reading and writing English

+ **Mathematical Skills:** Statistics skills desirable



**PREFERRED QUALIFICATIONS**



+ Strong working knowledge of cGMPs, U.S., F.D.A, ICH and other international regulations in the pharmaceutical industry.

+ Experience in Validation and Qualification of equipment and process



**PHYSICAL/MENTAL REQUIREMENTS**



+ Position requires regular onsite attendance, this position cannot be performed on a remote / telecommute basis



**WORK ENVIRONMENT:**



+ Use of required Safety equipment in GMP area as required.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Minimal travel requirements are expected

+ Position requires regular onsite attendance; this position cannot be performed on a remote / telecommute basis



**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.



**Last Date to Apply: November 21ST , 2019**



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Categories

Posted: 2019-11-08 Expires: 2019-12-08

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Compliance Specialist

Pfizer
Franklin, OH 45005

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