Members may be interested in the following vacancy at Pfizer Global Research & Development, Sandwich, Kent. Any queries via their careers website at http://www.pfizer.co.uk

Regards,

Eldin.

Job Title: Record Compliance Manager

Job Requisition#: 056365

Location: GBR - Sandwich

Department Marketing Statement: An opportunity has arisen with the Worldwide Regulatory Affairs & Quality Assurance area for a Record Compliance Manager as part of the Information & Records Management (IRM) Group .  This position will have responsibility for sponsorship of the Records Management Program and its application to the hard copy records maintained at the Pfizer Records Services [PRS] facility.  This will include change control management of the Records Retention Schedule, and an annual Compliance Program.  Additionally, this role will govern Vital Records preservation, and be designated as the Good Laboratory Practice (GLP) Archivist in accordance with regulatory requirements.  The incumbent will be the PRS liaison for any internal or external inspections, and liaise with Corporate Compliance to assure linkage with Corporate guidelines for Records Management.  This role will provide training/education on good Records Management practices for all business lines using the PRS for their inactive records storage, and offer subject matter expertise to IRM’s Information Management and Strategy lines with respect to incorporating Records Management principles within WRAQA systems.

Equal Employment Opportunity: Pfizer promotes a culture of inclusion and Pfizer Inc is an equal opportunity employer, committed to the hiring, advancement and fair treatment of individuals without regard to race, colour, religious belief, sex, sexual preference, age, national origin, ethnicity, disability or veteran status, or any other protected status designated by federal, state or local law.

In line with our Pfizer Value of “Respect for People”, we value differences as they lead to creativity and innovation, essential for the Pharmaceutical Industry.  We foster an inclusive culture in which all opinions are invited to be expressed, both in the work environment and through our Network Groups.  By embracing Diversity we support and encourage everyone to reach their full potential.

Job Type: Full Time

Qualifications: The essential qualifications for this role are as follows:·       

* MSC in Records Management Preferred 

*Or Diploma in Records Management & 4 years experience in Pharmaceutical industry

*Or 5 years experience in Pharmaceutical Records Management

* 4 years of direct experience as a professional Records Manager contributing to Corporate policies and Guidelines

* Strong partnerships, alliances within the business

*Understanding of all GxP requirements

*Ability to work effectively with people

*Ability to manage effectively and coordinate resources available

*Good oral and written communication skills

*Good project management skills - ability to perceive and analyze problems, develop alternatives and make or recommend sound decisions

Responsibilities: *Potentially manages the local colleague organization, setting goals, performance criteria, rewards, etc.

*Potentially promotes professional development through mentoring and motivating members of IRM

*Oversees record disposition in accordance with retention policies and established procedures

*Demonstrates competency in GxP archiving procedures

*Maintains certification as GLP archivist

*Maintains strong working knowledge of FDA, EU and other external regulatory and pertinent legal requirements

*Maintains strong working knowledge of company document management policies and procedures and oversees/ liaises with warehouse management to ensure their application across the PRS Facility

*Point of contact/host for any internal or external on-site inspection of records

*Assists in development, implementation and management of core business processes.

*Assists in development, implementation and management of records retention schedule, policies, procedures and record holds.

*Provides information to Global Assist/Customer base regarding standard records management practices

*Assists in development and delivery of training for PRS staff

*Ensures security and preservation of records in storage

*Maintains and ensures compliance with applicable regulatory requirements

*Responsible for annual Certification of Retention compliance

*Liaises with Corporate Compliance regarding Corporate Procedure #506 & Records Retention Schedule

*Identifies all gaps upon receipt of boxes, ensuring all information is archive ready

*Part of team to liaise with visitors to the PRS facility (Inspectors, Legal, etc.)

*Serves as a back up to other IRM members of PRS.

*Promotes quality achievement and performance improvement across the PRS facility.