Senior QA Specialist

QA Specialist (QC Support):

- We are looking for individual who can work independently, have good interpersonal skill and good laboratory compliance. The incumbent will have the responsibility for QA operational oversight for the site Quality Control (QC) and ensures overall quality integrity of the chemical and microbiological laboratories to support the testing, approval and release of API. The incumbent is also Quality approval for analytical and cleaning method _validation/verification,_ lab equipment qualification, laboratory procedures, and analytical reports etc and ensure adherence to site procedures and Pfizer Quality Standard /regulatory requirements. The incumbent will also be the Quality approval for laboratory _investigations/deviations_ and change controls related to laboratory._

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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 and Pfizer’s internal requirements.

Review and approve change control, deviation, customer complaint reports 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:
**Responsibilities**:

- Review and approve GMP documentation and ensure their compliance to Pfizer Quality Standards (PQS).
- Ensure adherence to quality procedures, regulatory requirements and cGMPs.
- Improve quality assurance systems, as necessary.
- Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
- Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss trends and atypical observations and recommend improvement actions.
- Conduct internal audits to ensure the internal controls are effective. Conduct external audits to ensure adequate oversight to suppliers and collaborate with supplier to reduce starting material quality issues.
- 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.

Job Relate Requirements:

- Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices (GDP), and other applicable regulations.
- Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing.
- Previous Quality Assurance and GMP Compliance experience.
- Demonstrated ability to interact effectively with management, auditors and regulators.
- Ability to interact effectively in teams and facilitate team discussions.

Accountabilities:

- Ensure compliance activities are carried out as per approved procedures and policies.
- Conduct internal audit to ensure compliance to Pfizer Quality Systems (PQS).
- Reviewing and approving change controls and deviation investigations.
- Reviewing and approving GMP documents.
- Manage GMP compliance systems

EDUCATION:

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

EXPERIENCE:

- For Senior QA Specialist: A minimum of 5 years’ experience in Quality Assurance role within the pharmaceutical industry
- 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: Flexible

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