Job Description

Why Patients Need YouEverything 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.Position SummaryThe incumbent is a member of the Quality Assurance team. Under the supervision of the Senior QA Manager / QA Manager, the incumbent will be responsible for the following: Provide Quality Assurance 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 behaviours 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 Quality Assurance team.This position will support operational readiness of a site extension followed by product manufacture. Key responsibilities in each phase are highlighted below: Operational Readiness phase Provide quality oversight of Facilities and Equipment, Materials, Production, Laboratories, Packaging and Labelling systems and processes. This includes supporting PQS gap analysis, review and approval of new and updated site procedures. Review and approve process recipes, master batch records, cleaning instructions and associated documentation to ensure batches produced are in compliance with Pfizer quality standards and regulatory registered specifications in support of initial process performance qualification of intermediate and active pharmaceutical ingredient (API) process steps. Provide support for updates to site platforms supporting quality systems (e.g. Trackwise, Vault QMS, SAP, PDOCs) as required. Play an active and impactful role to deliver flawless execution through critically reviewing systems, processes and interdependencies for GMP compliance and sustainability in routine operation.Routine production phase 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. Disposition intermediates and active pharmaceutical ingredients (API). 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. Handle product complaints. Ensure complaints are investigated thoroughly with effective CAPAs to prevent recurrence. 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. Coordinate with cross-functional team to prepare Annual Product Record Reviews, discuss 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. 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. 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 drive implementation of solutions. Collaborate with cross-functional teams to drive flawless execution. Mentor junior members (including interns) within the Quality Assurance team. Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).Job Related Requirements: Demonstrate ability to act decisively and independently to resolve issues. Strong verbal, written communication and presentation skills. Demonstrated ability to perform in a team and provide mentorship to team members. Possess a can-do / pride to succeed attitude Embrace the use of digital technology to scale and speed up every form of interaction and actionEducation: Degree in Chemistry, Microbiology, Engineering or other Science related discipline. Diploma in Science related discipline with a minimum of 6-8 years experience in Quality Assurance role within the pharmaceutical industry will be considered.Experience: Minimum 4 years experience (including Quality Assurance 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.Fully complete Covid-19 vaccination and can provide official medical certificate.
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