QA Specialist (Document Control)

Pfizer Inc.

Tuas, Singapore

Job posting number: #7134788 (Ref:pf-4880444)

Posted: March 17, 2023

Application Deadline: Open Until Filled

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.

POSITION SUMMARY

  • Support quality culture and promote GMP compliance behaviors to the site.
  • Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines.
  • administration for record management program and PDOC system
  • Manage and maintain the site document management system and ensure compliance with the Pfizer Quality Standards (PQS).
  • Work with cross functional teams to improve site document management systems and record archival/retention.
  • Understand regulatory expectations and support site inspection readiness.
  • document issuance, control and reconciliation of documents/forms.

POSITION RESPONSIBILITIES

  • Manage and ensure the site document management system including procedures, guidelines, templates, numbering, filing compliance to Pfizer Quality Standards (PQS) and ICH guidelines.
  • Ensure documentations are updated to the latest version and issued to shopfloor.
  • Ensure the control of changes / updates / filing/archival and retrieval in the document management system.
  • Distribution of effective documents to site wide
  • Control issuance and reconciliation of critical GMP forms used by various departments on site.
  • Review and approve GMP documentation and ensure their compliance to Pfizer Quality Standards
  • Ensure the site document retention schedule align with the Pfizer guidelines and meeting the regulatory requirements.
  • Manage the Record Management program – provide cataloging of the existing archival system, allocate archival space and issue proper retention schedule label code for department owners, monitor and track the space of archival room.
  • Arrange, manage and coordinate the physical destruction of documents with department owners and third-party contractors.
  • Periodic review of archived documents due for retention schedule,
  • Conduct training on record management program, document management system and coaching site users on document hierarchy, document structure and formatting requirement.
  • Support internal audits to ensure the internal controls are effective and alignment with the document control procedure/retention policy and the reconciliation requirement.
  • Maintain inspection readiness and support inspections from regulatory agencies and customers. Participate in GMP walk downs to ensure processes and systems are in compliance with regulatory requirements.
  • Support the maintenance of validated stated of GMP systems and processes.

EDUCATION

Diploma/bachelor's degree in science /Chemical Engineering or equivalent.

EXPERIENCE

For QA Specialist:  A minimum of 1 year experience in pharmaceutical industry or related industry is preferred.  Fresh graduate will still be considered.

For Diploma holders, a minimum of 3 years experiences in pharmaceutical industry or related industry.

  
Work Location Assignment: On Premise

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

Quality Assurance and Control

#LI-PFE


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.


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More Info

Job posting number:#7134788 (Ref:pf-4880444)
Application Deadline:Open Until Filled
Employer Location:Pfizer Inc.
New York,New York
United States
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