Quality Assurance Coordinator

1 day ago

Makkah, Makkah Province, Saudi Arabia Pfizer Full time
Why Patients Need You

Pfizer's commitment to quality and safety is unwavering. Our science and risk-based compliant quality culture is flexible, innovative, and customer-oriented. As a member of our dedicated quality assurance and control team, you will play a crucial role in ensuring the delivery of safe and effective products to patients.

What You Will Achieve

You will be responsible for quality oversight for change control systems and product change control oversight with Regulatory Affairs. You will also support non-manufacturing functions, quality strategic planning, performance metrics, and quality goals and objectives. Additionally, you will provide related oversight for other functions.

As an associate, your focus on the job will contribute to 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 Pfizer achieve new milestones and help patients across the globe.

How You Will Achieve It

  1. Manufacturing and Packaging Batch Records Issuance.
  2. Follow up batch records workflow, and thorough comprehensive review of batch records and documentation to ensure strict adherence to written procedures and compliance with data integrity.
  3. Apply GMP rules during review of batch records.
  4. Ensure the data of the batch of a product are correct on the ERP system, and forward the status of the product.
  5. Ensure data of the batch is correctly reflected into SAP/ATTP and SFDA portal (RSD).
  6. Manage samples of products.
  7. Reject rejected FGs and locally manufactured SFGs.
  8. Report and initiate any major or critical incident observed during batch record review.
  9. Responsible for batch record archiving.
  10. Initiate and review SOPs related to batch disposition & serialization and ensure adherence to the SOP after completion of its training.
  11. Process Orders (POs) and Finance routings review and preparation.
  12. Review and approve Bill of Material (BOM) and Engineering Change Order (ECOs).

Qualifications

To be successful in this role, you must have:

Must-Have

  1. Bachelor's degree in Pharmacy or a related field.
  2. Saudi National.
  3. 4 years' experience in GMP environment.
  4. Ability to interpret documents such as cGMP/(s)FDA regulations, standard operating procedures.
  5. Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries.
  6. Ability to report results clearly and concisely & quickly analyze and solve problems.
  7. Ability to work independently and within teams.
  8. Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives.
  9. PC literate with different applications/systems; e.g. MS Excel, Word, PowerPoint, etc.

Nice-to-Have

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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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