QA Qualified Person Coordinator

at  Pfizer

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.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in quality oversight for change control system and product change control oversight with Regulatory Affairs. You will also be relied on to support non-manufacturing functions, quality strategic planning, performance metrics and quality goals and objectives. You will also quality provide related oversight for other functions.
As an associate, your focus on the job will contribute in achieving project tasks and 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 help make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Manufacturing and Packaging Batch Records Issuance.
• Follow up batch records workflow, and thorough comprehensive review of batch records and documentation and ensure strict adherence to written procedures and ensure compliance with data integrity.
• Follow up on applying of GMP rules during review of batch records.
• Ensure the data of the batch of a product are correct on ERP system, and ERP-forward the status of the product.
• Ensure data of the batch is correctly reflected into SAP/ATTP and SFDA portal (RSD).
• Retain samples management of products.
• Rejection of rejected FGs and locally manufactured SFGs.
• Reporting and initiation of any major or critical incident observed during batch record review.
• Responsible for batch record archiving.
• Initiate and review SOPs related to batch disposition & serialization and ensure adherence to the SOP after completion of its training.
• Process Orders (POs) and Finance routings review and preparation.
• Bill of Material (BOM) and Engineering Change Order (ECOs) review & approval.

Qualifications

Must-Have

• Bachelor’s degree of Pharmacy or any related field.
• Saudi National.
• 4 years’ experience in GMP environment.
• Ability to interpret documents such as cGMP/(s)FDA regulations, standard operating procedures.
• Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries.
• Ability to report results clearly and concisely & quickly analyze and solve problems.
• Ability to work independently and within teams.
• Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives.
• PC literate with the different applications/systems; e.g. MS Excel, Word, PowerPoint, etc.

Nice-to-Have

• Certified Lean Six Sigma Green Belt
• Demonstrated ability to learn and master new applications software
• Experience in conducting and documenting manufacturing incident or customer complaint investigations

Please refer the Job description for details