Pfizer Hiring For QA Specialist (Batch Release) at Tuas Full Time

QA Specialist (Batch Release)

Pfizer–Tuas

41 minutes ago, from Pfizer Global

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.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a QA Specialist, your focus on the job will contribute in achieving site goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

Position Summary

• 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 and processes.

• Understand regulatory expectations and support site inspection readiness.

• Oversee adequate quality oversight to supplier management to ensure starting materials used meet Pfizer Quality Standards (PQS).

• Work with supply chain and drug product sites to ensure timely delivery of quality products.

• work with GCMC to file products and address regulatory queries in an accurate and timely manner

Position Responsibilities

• Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and active pharmaceutical ingredients (API) to ensure batches produced are in compliance with Pfizer quality standards and regulatory registered specifications.

• Disposition the intermediates and active pharmaceutical ingredients (API).

• Review and approve cleaning records and procedures and ensure compliance with the Pfizer Quality Standards (PQS) and guidelines.

• 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.

• Review and approve deviations according to the site procedures. This includes reviewing and approving the investigation reports, ensuring the adequacy of the associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/regulatory impact. Ensure issues are escalated according to the Pfizer Quality Standards (PQS).

• 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.

• 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.

• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner

Organizational Relationships

• the position will interact with all site departments for GMP related operations and activities i.e. Manufacturing Operations Process Teams, Quality Control, Warehouse and Tank farm teams and Engineering teams.

Education

Bachelor’s Degree in Science/Chemical Engineering or equivalent.

Experience

For Senior QA Specialist: A minimum of 4 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.

 
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.

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