Di & Compliance Coordinator

2 weeks ago

المملكة العربية السعودية, Saudi Arabia Pfizer Full time

Position Summary:

- Role as Site Quality Compliance Team member with primary focus to ensure that the site is in a steady, ready, and prepared state for Inspection Readiness.
- Maintain Site Master File and update it when required.
- Ensure that appropriate systems are in place to meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured on site.
- Follow up with all departments the Compliance Analysis Status of applicable Pfizer Quality Standards.
- Ensure on time responding to audits and audit observations.
- Quality Reviewer and approver for packaging Artwork.
- Facilitate appropriate site-based initiatives to ensure effective roll-out of Data Integrity program elements launched by center.

Job Specific Technical / Functional / Professional Competencies:

- Responsible for Data Integrity Management:

- Work with the colleagues at site to develop and maintain a robust site strategy, including action plans to ensure data management practices are compliant with Pfizer and regulatory expectations.
- Plan, preform and review Audit Trail Assessment & backup process for the site under the site Data Integrity requirements.
- Coordinate and participate in the Data Integrity “walkthroughs” including site leadership walkthrough.
- Provides Data Integrity program risk information as an input to the IR process.
- Site Inspection Readiness:

- Collaborate with site colleagues and leadership to develop and maintain a written Inspection Readiness (IR) Site Plan per the IR Center standard or equivalent.
- Work with the Center Inspection Readiness Team to drive site strategy and IR maturity.
- Leverage inspection intelligence and site data to identify hot topics, and work with local SMEs to resolve and develop their story.
- Being part of Site Self-Assessment (internal audit) team and partner with team members to focus on potential areas of inspector inquiry.
- Define and actively monitor inspection related metrics, seeking out trends and communicating and escalating, as necessary.
- Communicate audit plans with site personnel.
- Distribute Executive Summary notes to SRI distribution lists by start of next business day.
- Responsible for Internal Audit System:

- Preparing annual audit plan, participate and manage audit execution, communicate with audited departments.
- Reviewer of performed audits and assigning required corrective / preventive actions and follow up for their closure throughout different site areas.
- Responsible for Management Review (SQRT):

- Planning, preparation and organization for management reviews.
- Data collection and summarization of annual quality activities to site leader ship team.
- Follow up for arising management actions and archiving of related documentation.
- Responsible for CAS report follow up:

- Ensuring the CAS reports of applicable PQSs in the site are completed.
- Assignment of actions to guarantee compliance with PQSs (if required).
- Responsible for Site Master File:

- Maintain Site Master File and update it when required.
- Responsible for Quality risk management:

- Support, plan and maintain site quality risk management profile and escalate appropriately.
- Responsible for Artwork Approval:

- To review and approve all received packaging Artwork on EPALMS.

Experience and Knowledge:

- University bachelor degree in Science, engineering or equivalent.
- 3 years’ experience in pharmaceutical manufacturing preferably in Quality Compliance, Data Integrity, and Artwork and Review.
- Ability to read English and interpret documents such as cGMP/ SFDA regulations, standard operating procedures, and Pfizer corporate policy manuals.
- Ability to report results clearly and concisely. Sound reasoning and ability to quickly analyze and solve complex problems.
- Excellent attention to detail.

Essential Personal Qualifications:

- Good command of English both written and spoken.
- Knowledgeable with interpersonal learning.
- Good communication skills.
- Logic way of thinking
- High analytical skills

LI-PFE

Work Location Assignment: On Premise

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

Regulatory Affairs

LI-PFE

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