Support timely implementation of all applicable Product Quality SOPs (issued by SCMOQ) within the PCO.
Ensure that all relevant PCO colleagues are appropriately trained in the Product Quality SOPs.
Assess new quality system and local regulatory requirements to enhances and align local systems and processes when required.
Conduct and document periodic assessments to determine if a revision, retirement, administrative change or no change is required for the Product Quality SOPs (issued by SCMOQ) within the PCO.
Manage commitments resulting from deviation management, change control, local regulatory authorities’ inspections, and internal audits.
Use and maintain tracking tools to track any GxP commitments raised by SCMOQ or under SCMOQ oversight.
For any commitment opened, ensure that due dates are based on risk, complexity and urgency, and that the timeframes given are realistic, to meet the stated requirements.
Completion of all commitment tracking actions as per assigned due dates
Lead the preparation and coordination of GMP/GDP related inspections of PCO Pfizer internal/MSQA audits
Work with SCMOQ Market lead and local functions to prepare an appropriate action plan to address the inspection/audit observation
Site Internal Audit (SIA) process management:
Ensure that relabeling sites have been trained and approved before performing any relabeling activity.
When required, ensure that the relevant Regulatory approval for the relabeling activity has been obtained by the regulatory team.
Complete the required documentation and obtain the necessary approvals from Pfizer relevant functions.
Oversee the process of relabeling and review operation related documents.
Ensure SCMOQs release (as applicable) of the relabeled product according to Pfizer and local requirements
Has an appropriate education in science or quality topics; Bachelor's degree, Pharmacist, Engineer.
Has basic knowledge of the Quality principles, concepts of Quality and basic technical skills
Has basic knowledge about Quality Systems (Change Control, deviations, complaint management, documentation management, audits, inspections, etc.)
Able to Participate effectively in cross-functional team
Analytical skills
Excellent level in English
Self-motivated, Business acumen
Acts Assertively
Grows Self
Accountable
Change Agile
Self-Awareness
Planning & Organizing skills
Able to make decisions within guidelines and policies
To use new ideas and knowledge with increasing frequency, begins to explore and apply ingenuity to experimentation.
Able to work in ambiguous situations as part of a Work Team
Applies technical skills to achieve assigned tasks
Has effective communication, writing and negotiation skills
Able to align with global strategies
* Efficiently represents Quality Compliance positions