Sr QO Specialist – Business Systems Validation (1st shift)

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

In your role, you will be joining a teamthatis accountable for assuring the compliant validation of information technology systems. Your work will involvecreatingformal validation documentation (including standard operating procedures)asper governmental regulationsandcoordinating activities with clients, programmers/developersand operating personnel, in-country or global, as appropriate.

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 important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

It is your dedication and hard work that will make it possible for customers and patients to receive the medicines they need, when they need them.

How You Will Achieve It

• Contribute to the completion of moderately complex projects.

• Manage own time to meet agreed targets.

• Develop plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team.

• Provide guidance and Quality oversight of the validation of automated Systems (Engineering, Manufacturing and Laboratory Equipment and Information Technology) ensuring compliance to applicable regulations.

• Review and approve System Development Life Cycle (SDLC) documentation, investigations and change controls related to enterprise Business Technology (BT) supported computer systems.

• Support site Data Integrity (DI) program, Change Controls, performing automated systems related investigations and internal audits as required.

• Perform Periodic Reviews, Security Reviews and System administration oversight of site automated systems.

• Review and approve the implementation/compliance documentation forGxPand non-GxPsystems against good IT practices and regulatory codes for automated systems.

• Assist with departmental reporting initiatives; develops and issues weekly/monthly metrics (ie, Reliability Room postings, Weekly QRB report, Management Review and Trend reports).

• Implement available tools to ensure reduction of human performance related deviation.

Qualifications

Must-Have

• ​Applicant must have 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

• Good understanding of GMP, GDP, ALCOA principles, 21 CFR part 11 and PIC/s.

• Strong project management skills.

• Strong communication (written and verbal) skills.

• Excellent facilitation skills and ability to facilitate strategy meetings.

• Expertise with word-processing, spreadsheet and presentation software.

Nice-to-Have

• Experience with system validation and system administration requirements inclusive of Database Management Systems (DBMS), Application implementation, Network Infrastructure (network devices, servers, operating systems), IT security and Web Technologies.

• Experience with laboratory systems, automated manufacturing systems (SCAD, PLC, HMI), Network Qualification.

• Experience in Validation principles and validation documentation.

PHYSICAL/MENTAL REQUIREMENTS

Ability to focus for prolonged periods on difficult and complex technical tasks.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Some off-hours support may be required. No travel is expected in this role. This position will be expected to be in the office environment a minimum of three (3) days during an average work week.

Work Location Assignment:On-Premise (flexible)

Last date to apply- 10/10/2022

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.