Senior QA Specialist

Why Patients Need You
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.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
Position Summary
The incumbent is a member of the Quality Assurance (QA) Operations team. Under the supervision of the Senior QA Manager / QA Manager, the incumbent will be responsible for the following:

• Provide QA oversight to site operations (primarily Production, Quality Control, Warehouse, Engineering) to ensure products produced are in compliance with Pfizer Quality Standards (PQS) and ICH guidelines.
• Work with supply chain and downstream / drug product sites to ensure timely delivery of quality products.
• Support regulatory team to file products and address regulatory queries in an accurate and timely manner.
• Understand regulatory expectations and support site inspection readiness.
• Drive quality culture and promote GMP compliant behaviors at the site.
• Drive improvement of quality systems in collaboration with cross functional teams.
• Contribute to achieve our vision of being best in class manufacturing site, producing highest quality products in the safest way.
• Deploy and use Imex "way of working" for day-to-day operations, problem solving, escalation and continuous improvements.
• Mentor members within the QA team.

How You Will Achieve It

• Provide QA oversight to specific departments / areas (e.g. Production, Engineering, Quality Control etc).
• Responsible to review and approve recipes and GMP documentation (e.g. SOPs, batch records, change controls) associated with Facilities and Equipment, Materials, Production, Laboratories, Packaging and Labelling to ensure batches are produced and tested in compliance with site procedures and regulatory registered specifications.
• Collaborate in cross function teams (e.g. Production, Quality Control, Warehouse, Supply chain personnel) to provide QA support for end-to-end adherence to production schedule while ensuring GMP compliant outcomes.
• Review and approve deviations and laboratory investigations according to site procedures. This includes reviewing and approving the investigation reports, ensuring the adequacy of the root cause analysis and associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/stability/regulatory impact. Ensure issues are escalated according to site procedures.
• Disposition intermediates and active pharmaceutical ingredients (API).
• Coordinate with cross-functional team to prepare Annual Product Record Reviews, analyze trends and atypical observations and recommend improvement actions.
• Participate in process risk assessments (e.g. FMEA) as part of new product introductions and/or process changes.
• Site subject-matter owner of specific QA-related PQS, including site representation of global PCTs (process centric teams) for QMS topics (as nominated).
• Handle duties related to DPOC (Designated Point of Contact) and super user for assigned site platforms supporting quality systems (e.g. Trackwise, Vault QMS, SAP) (as nominated).
• Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
• Participate in gap analysis of site procedures against PQS and propose required actions to address identified gaps and mitigate risks. Conduct internal audits to ensure the internal controls are effective (as nominated).
• 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 and adhere to site procedures and PQS.
• Support the maintenance of validated state of GMP systems and processes.
• Support regulatory submissions and attend to regulatory queries in a timely manner.
• Uphold Pfizer's code of conduct and values.
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and implement solutions.
• Collaborate with cross-functional teams to drive flawless execution.
• Mentor junior members (including interns) within the QA team.
• Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).

Job Related Requirements

• Ability to act decisively and independently to resolve issues, escalating issues as required.
• Ability to perform in a team and provide mentorship to junior team members.
• Strong verbal, written communication and presentation skills.
• Possess a can-do / pride to succeed attitude
• Embrace the use of digital technology to scale and speed up every form of interaction and action.

Qualifications and Experience

• Degree in Chemistry, Microbiology, Engineering or other Science related discipline
• Minimum 4 years experience (including QA roles) within the pharmaceutical industry.
• Compliance, regulatory or validation experience is an advantage.
• Strong written and oral communication skills. Technical report writing skills is an advantage.
• Demonstrated personal leadership, accountability, and organizational skills with proven ability to operate independently with minimal supervision. Experience working in a cross-functional, matrix environment is an advantage.

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