Pfizer QA Specialist (Manufacturing) in Tuas, Singapore
We are looking for individual who has experience in supporting the manufacturing value stream on deviation & complaint investigation, CAPA, change control, annual product review and new product introduction for active pharmaceutical ingredient (API) operation that is in full compliance with Global cGMP guideline and Pfizer Quality Standards (PQS). The incumbent will have to provide functional ownership and accountability for the value stream to ensure products produced met regulatory and PQS requirement.
The incumbent will establish, maintain, coordinate and support the Quality Systems Compliance such as Change Control, Deviation, Supplier Qualification, Internal Audits, Regulatory Inspections, Customer Complaints and GMP Training to support the various business processes on site in full compliance with GMP predicate rules and Pfizer's internal requirements.
Train site personnel on such systems and act as a key user / system administrator for such systems on site. 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.
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.
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).
Handle product complaints. Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
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.
Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner
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.
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 e.g. QTS, PDOCS
The incumbent 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. In the event of quality or regulatory related issues, this position will interact with quality or regulatory representatives from drug product sites or Global Chemistry Manufacturing & Compliance (GCMC) teams.
A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience. Familiar with the self-directed team concept; manufacturing operations applications; six sigma and lean principles and process improvement tools.
E XPERIENCE :
A Minimum 3-5 years' experience in pharmaceutical GMP-regulated industries (Biotech preferred) and minimum 3 years' thereof in Quality Assurance/Compliance roles within the pharmaceutical industry.
Flexi Compressed Work (Singapore)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.