QA Specialist

1 week ago

Tuas, Singapore Pfizer Full time

The incumbent will establish, maintain, coordinate and support the Quality Systems Compliance such as Change Control, Deviation, Internal Audits, Regulatory Inspections and GMP Training to support the various business processes on site in full compliance with GMP predicate rules, regulatory requirements and Pfizer’s internal requirements.

Review and approve change control, deviation to ensure consistency with quality standards and quality of deliverables as and when required.
- Drive quality culture and promote GMP compliance behaviors to the site.
- Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines.
- 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 quality systems.
- Understand regulatory expectations and support site inspection readiness.

POSITION RESPONSIBILITIES
- Review and approve GMP documentation and ensure their compliance to Pfizer Quality Standards (PQS) and regulatory requirements
- Ensure adherence to quality procedures, regulatory requirements and cGMPs.
- Improve quality assurance systems, as necessary.
- Write deviations according to the site procedures. Ensure issues are escalated according to the Pfizer Quality Standards (PQS).
- Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
- Support the maintenance of validated stated of GMP systems and processes.
- 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
- Control issuance and reconciliation of critical GMP forms used by various departments on site
- 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 contractor

EDUCATION

A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.

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

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