Senior QA Specialist

1 week ago


Singapur, Singapore Pfizer Full time
Quality Assurance Specialist (QC Support) at Pfizer

We are searching for an individual who can work autonomously, possesses strong interpersonal skills, and demonstrates good laboratory compliance. The role entails overseeing QA operations for the Quality Control (QC) department to uphold the quality integrity of chemical and microbiological laboratories involved in testing, approving, and releasing API. The incumbent also holds responsibility for approving analytical and cleaning method validation/verification, lab equipment qualification, laboratory procedures, analytical reports, and ensuring adherence to site procedures, Pfizer Quality Standard, and regulatory requirements.

Position Summary:

The incumbent will be in charge of establishing, maintaining, coordinating, and supporting Quality Systems Compliance, such as Change Control, Deviation, Internal Audits, Regulatory Inspections, and GMP Training to ensure full compliance with GMP rules and Pfizer's internal requirements.

  • Foster a quality culture and encourage GMP compliance behaviors within the site.
  • Uphold site compliance with Pfizer Quality Standards (PQS) and ICH guidelines.
  • Provide oversight of site GMP operations to guarantee products are manufactured in compliance with Pfizer Quality Standards (PQS).
  • Collaborate with cross-functional teams to enhance quality systems.
  • Understand regulatory expectations and assist in site inspection readiness.
Position Responsibilities:
  • Review and approve GMP documentation for compliance with Pfizer Quality Standards (PQS).
  • Ensure adherence to quality procedures, regulatory requirements, and cGMPs.
  • Enhance quality assurance systems as needed.
  • Review and approve deviations following site procedures. This includes assessing investigation reports, validating corrective actions, performing impact assessments, and ensuring escalation according to Pfizer Quality Standards (PQS).
  • Maintain quality tracking systems and metrics to spot trends and anomalies proactively.
  • Collaborate across teams to prepare Annual Product Record Reviews, analyze trends, and recommend improvements.
  • Conduct internal and external audits to verify effective controls and supplier oversight.
  • Ensure inspection readiness and support regulatory inspections.
  • Support the maintenance of validated GMP systems and processes.
Job Related Requirements:
  • Profound knowledge of GMP compliance regulations, ICH Q7a Guidelines, GDP, and other regulations.
  • Proven track record in continuous improvement and implementing best practices in quality operations.
  • Previous experience in Quality Assurance and GMP Compliance.
  • Demonstrated ability to engage effectively with management, auditors, and regulators.
  • Skill in team interaction and facilitation.
Accountabilities:
  • Ensure compliance activities align with approved procedures and policies.
  • Conduct internal audits to uphold Pfizer Quality Systems (PQS) compliance.
  • Review and approve change controls, deviation investigations, and GMP documents.
  • Manage GMP compliance systems.
Education:
  • Bachelor's Degree in Science/Chemical Engineering or equivalent with relevant pharmaceutical experience.
Experience:
  • Senior QA Specialist: Minimum 5 years' experience in Quality Assurance within the pharmaceutical industry.
  • QA Specialist: Minimum 1 year experience in the pharmaceutical industry preferred, fresh graduates considered.
  • Diploma holders: Minimum 3 years' experience in pharmaceutical industry or related fields.

Work Location Assignment: Flexible

Pfizer is proud to be an equal opportunity employer, complying with all relevant equal employment opportunity legislation in each jurisdiction of operation.


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