The successful candidate will operate as a Quality Operations Validation Professional. In this role, they will provide oversight of the execution of the validation system, ensuring that contemporary compliance standards and conformance to site procedures are maintained. The ideal candidate will possess skills and experience in both equipment validation, and automation/computer validation.
ROLE RESPONSIBILITIES
Reviews validation impact assessments for new equipment/processes and changes to existing qualified systems and automation. Reviews and approves verification and change control documentation supporting all changes to equipment, and new equipment. Reviews and approves validation protocols and reports. Supports validation as an SME during customer and regulatory audits for all areas of responsibility. Represents the unit as a customer interface on equipment installation teams to support all phases of validation.
Participates in execution of unit performance objectives. Supports and facilitates compliance initiatives. Supports the unit where needed to assure due dates and customer needs are met. Performs additional tasks as determined by the department manager to support the unit.
QUALIFICATIONS
A BA/BS degree or higher in a science discipline with 4-8 years of experience, preferably with GMP and/or pharmaceutical validation and change control experience. Excellent written and verbal communication skills, with the ability to interact with senior leadership and regulatory agencies.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Weekends and/or holidays may be required.
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.
Last Date to Apply: October 8, 2018
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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.
