The Senior QA Specialist evaluates clinical and commercial batches, ensures compliance with standards, conducts investigations, and supports regulatory submissions.
- 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.
Position Summary
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 Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
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 QMS, 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- Degree in Chemistry, Microbiology, Engineering or other Science related discipline.
- Diploma in Science related discipline with a minimum of 10 years experience in Quality Assurance role within the pharmaceutical industry will be considered.
- Minimum 4 years experience in a Quality Assurance role 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 could provide official medical certificate
Pfizer Singapore recruit permanent employees for manufacturing site expansion of PFIZER ASIA MANUFACTURING PTE LTD (PAMPL) in Singapore
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
#LI-PFE
Top Skills
Gmp
SAP
Trackwise
Vault Qms
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