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Pfizer Document Control Supervisor in Tuas, Singapore

POSITION SUMMARY

The incumbent is member of the QA team overseeing site wide document management systems and record management program. The incumbent will be responsible to drive quality culture and promote GMP compliance behaviors, ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines and provide oversight to the site GMP operations to ensure products produced in compliance with the Pfizer Quality Standards (PQS).

  • Collaborate with cross functional teams to improve site document management systems and record archival/retention.

  • Understand regulatory expectations and support site inspection readiness.

  • Work with all site functions on document issuance, control and reconciliation of documents/forms.

POSITION RESPONSIBILITIES

Responsibilities:

  • Develop, maintain 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 shop floor

  • Ensure control of changes / updates / proper filing/archival and easy retrieval in the document management system

  • Overall in-charge of distribution of documents

  • Control issuance and reconciliation of critical GMP forms used by various departments on site and the use is meeting the data integrity requirements.

  • Ensure the site document retention schedule align with the Pfizer guidelines and meeting the regulatory requirements

  • Be a central controller for 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,

  • Provide training on record management program, document management system and coaching site users on document hierarchy, document structure and formatting requirement.

  • Conduct internal audits to ensure the internal controls are effective and alignment with the document control procedure/retention policy and the reconciliation as per Data Integrity requirement.

  • Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure processes and systems are in compliance with regulatory requirements and Data Integrity requirement.

  • Support the maintenance of validated stated of GMP systems and processes.

EDUCATION

Diploma in CPT/ Degree in relevant field

EXPERIENCE

Minimum 6 years of relevant experience in Document Management System (document control and archival) in Pharma Industry.

#LI-PFE

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

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