Senior Validation Specialist Pfizer
Lake Forest, CA

Job Description

ROLE SUMMARY

Assure that the Pfizer Innovative Health (PIH) PSSM R&D validation program remains in compliance with Pfizer corporate policies and procedures and applicable federal regulations. Provide consultation and assistance to (PIH) PSSM R&D personnel on validation/qualification and Data Integrity, including activities such protocol/report drafting and change management. Participate in inspections by external areas, including (PIH) PSSM Quality, FDA etc. Participate on cross-functional project teams to help resolve validation/qualification and Data Integrity issues. Identify, develop and implement validation/qualification and Data Integrity continuous improvements initiatives. Maintain industry and regulatory knowledge of new and evolving validation/qualification and Data Integrity requirements and trends. Communicate these requirements and trends to management and develop plans to assure (PIH) PSSM R&D is in compliance with new requirements. Recognize validation/qualification and Data Integrity issues and lead cross-functional project teams to help resolve validation/qualification issues. Represent (PIH) PSSM R&D on corporate validation/qualification and Data Integrity initiatives. Maintain Validation Master Plan and update system inventory as required.

ROLE RESPONSIBILITIES

Anticipate and adjust to changing priorities and anticipate the impact of change to the organization. Recognize and resolve compliance issues impacting validation/qualification and Data Integrity and communicate these issues to (PIH) PSSM personnel. Maintain industry knowledge of new and evolving validation/qualification and Data Integrity requirements and trends. Interpret and communicate these requirements and trends to management and develop plans to assure (PIH) PSSM is in compliance with new requirements by maintaining validation/qualification and Data Integrity documentation. Support the Manager, R & D Systems, and (PIH) PSSM R&D by supervising the activities involved in implementation and maintaining validation/qualification and Data Integrity programs throughout the (PIH) PSSM R&D organization. Assist with external audits and in developing formal responses to audit observations. Identify, lead and implement validation/qualification and Data Integrity improvement projects, coach and train R&D Validation Specialists or Compliance Specialists, provide guidance to (PIH) PSSM personnel on validation/qualification and Data Integrity, and evaluate the potential risk of compliance deficiencies. Extremely detailed oriented in originating and processing required Quality documentation. Applies high level of knowledge of Standard Operating Procedures to ensure high degree of accuracy in fulfilling job quality requirements. Ability to use knowledge and experience to make quality decisions with little or no Management input. Uses discernment and discretion to know when to escalate important quality decisions to management. Applies initiative and ingenuity to job functions. Looks for continual improvements through organizational and technical means.

QUALIFICATIONS

* Bachelor's Degree is required
* 5-10 years of Quality or professional engineering experience
* 3-7 years of experience in a R & D Scientist or Engineer role (secondary)
* This position requires thorough knowledge of the effect of validation/qualification and Data Integrity programs upon the product development cycle.

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.

Other Job Details

* Last Date to Apply for Job: June 29, 2019

1 (First Shift) (United States of America)

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