ROLE RESPONSIBILITIES for QA Coordinator (Contractor)
Responsible for Change Control system:
- Responsible for providing supportive information for variation/change control documents, managing implementation of changes within KAEC Site, handling, reviewing, approval and follow-up of Change Control requests and actions
Responsible for Document Control:
- Maintain the document control system.
- Management of Pfizer Document Management System (PDOCS) and act as a Document Manager responsible for routing documents for review and approval.
- Act as a Documentation Point of Contact (DPOC) for the site.
- Printing Master Batch Record.
- Follow up on the SOPs progress of the site
Responsible for Training System Management:
Maintain a GMP Training Program that complies with Good Manufacturing Practice (GMP) Regulations, PQS and site procedures for both the KAEC site & the Logistics KAEC group.
Oversees the design, development, and implementation of GMP training at the site, including the orientation and induction of all new colleagues and Contingent Workers.
Ensure compliance with regulatory requirements training initiatives and Pfizer standards through fulfilling all the required technical training successfully and coordinating all technical aspects related to new and existing requirements and/ regulations.
Ensure technical training documentation (Job function Curricula, training materials, training records.) is promptly and accurately completed and maintained.
Coordinate & document process of all external & internal trainings.
Prepare training performance reports for all departments in the site.
Prepare overdue trainings report and follow up with the concerned colleagues completion of overdue trainings.
Backup for Review Master Batch records and any other GMP documents as required.
Backup for handling of retained sample room.
Backup for release & reject status labelling of finished goods following applicable SOPs.
Follow up applying of GMP rules during review of batch documentation.
BASIC QUALIFICATIONS
- Good command of English both written and spoken.
- Logic way of thinking.
- Management and decision making skills.
- High analytical skills.
- Communication & high interpersonal skills.
- simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives.
- Excellent in communication and project management
- Decision-making based on a risk science based approach
- Willing to embrace innovation and change in order to find solutions.
- Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries
- Ability to report results clearly and concisely.
- Sound reasoning and ability to quickly analyze and solve complex problems
- Excellent attention to detail and time management skills
- Ability to work independently and with work 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 following applications: MS Excel, Word, PowerPoint
PREFERRED QUALIFICATIONS
- Train the trainer certified
- Trained on QAR investigator curricula
- Quality Risk Management (QRM)
- Experience with relevant QTS modules
- Project Manager, team leader/project leader and coach
- Committed to the Investigations One Best Way to enable QAR reduction and a general improvement of the Investigations System
Work Location Assignment: On Premise
#LI-PFE
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
