Job Description

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

You will be a member of Pfizers dedicated and highly effective quality assurance team. You will evaluate and review Pfizers clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues. It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

* Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
* Create, review and approve Good Manufacturing Practices {also cGMP} audit reports.
* Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
* Create, review and approve deviations and consistently produce quality work.
* Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact.
* Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
* Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
* Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
* Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
* Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
* Help to define appropriate action plans for improvement and follow-up and communicate action closures.
* Lead/Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.

ROLE RESPONSIBILITIES:

The essential functions of the position may include, but are not limited to:

* Reviews Batch Records for compliance to SOPs and determination of batch acceptability.
* Determines batch acceptability for further processing, reject or release
* Assists in the issuance of batch records to manufacturing, stability test reports and control/archival of in-process and completed records
* Quarantines and rejects material as needed, including PRISM transactions
* Assists and supports the manufacturing/packaging staff in detecting and solving compliance errors in the manufacturing and packaging operations.
* Adresses third party audit findings.
* Supports customer and regulatory audits
* Collects/Trends data, participates in M1, yellow belt, green belt projects as assigned.
* Other tasks as assigned by management

QUALIFICATIONS:

* BS in Chemistry, Biology, Microbiology, Pharmacy, Engineering or other science related discipline
* Experience: 0-2 years GMP pharmaceutical experience and/or Manufacturing Quality Assurance experience.
* Independently consistently produces quality work.
* Works in a team environment within own team and interdepartmental teams.
* Must work under short timelines while maintaining quality work.
* Must have effective written and oral communication skills
* Experience at a manufacturing site preferred.
* Experience in Batch Record Review/Audit/Disposition preferred.
* Knowledge of FDA and International regulations preferred.

PHYSICAL/MENTAL REQUIREMENTS

Able to deal with frequent change, delays, and/or unexpected events. Must work under short timelines while maintaining quality work, on-site attendance required. Interfaces with management and non-management employees in manufacturing, packaging, engineering, pharmaceutical technology, regulatory affairs, quality assurance and laboratories.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Split shift 11:00am-7:30pm Monday-Friday with potential for weekend shifts and/or 2nd shift 1:00pm-9:30pm to support production.

The job is open only to Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (green card holders), Refugees and Asylees.

Last Date to Apply for Job: January 22, 2021

Eligible for Employee Referral Program

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 providers 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.

Quality Assurance and Control

LI-PFE