Quality Control Section Head

12 hours ago

مصر, Egypt Viatris Full time

3803 Viatris Egypt S.A.E
- At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.Every day, we rise to the challenge to make a difference and here’s how the (Quality Control Section Head) role will make an impact:

- Position summary:

- Responsible for release of in-process materials and finished goods during its manufacturing stages and all related activities.
- Managing all laboratory resources safely and efficiently. Responsible for all aspects of the laboratory including equipment, employees, supplies, software and documentation.
- Job Specific technical/Functional/Professional Competencies:

- Responsible for the finished goods laboratory section functions including in-process materials and corresponding documentation to support the timely disposition of product.
- Managing all FG laboratory section resources efficiently, responsible for all aspects of the laboratory including equipment, employees, supplies, software and documentation.
- Responsible for ensuring that all results generated are in compliance with data integrity requirements.
- Responsible for finished goods equipment calibration & maintenance.
- Maintains laboratory supplies inventory required for chemical analysis.
- Coordinating schedule with other departments (Planning, Production).
- Supervise operational requirements by scheduling and assigning employees; following up on work results.
- Maintains FG laboratory equipment performance by establishing quality standards; developing operations and quality procedures; ensuring staff compliance; certifying instrument performance; arranging equipment replacement, service, and repair.
- Maintains laboratory supplies inventory required for FG analysis by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.
- Supporting validation department in execution of process validation activities and cleaning validation.
- Approval of finished products release documents.
- Reviewing and approval the process validation and cleaning validation protocols and reports.
- Training the analysts on the implementation of current new SOPs, Standard Test Procedures (STPs) and new techniques in the analysis. Document and approve the training documents.
- Reviewing and approval the required SOPs related to chemical laboratory tasks and ensuring that these procedures are strictly followed during laboratory practices.
- Coaching and developing chemical laboratory colleagues to achieve high performance.
- Trouble shooting for section problems and instruments malfunctions.
- Reviewing the Analytical Method Transfer Exercise (AMTE) results from local (new analysts, new test procedures) and from labs in other companies and/or countries and supporting them.
- Review / approve laboratory investigation reports (LIR) for out-of-specification FG results.
- Responsible for endorsement of GLP requirements during laboratory practices.
- EHS committee member, ensuring implementation of EHS measures/actions within QC laboratories.
- Coaching colleagues with their improving projects and sponsoring their projects.
- Implements new programs, tests, methods, instrumentation and procedures by investigating alternatives; preparing proposals; monitoring progress.
- Supports QA with all CCRs and QARs related to the section.
- Responsibility for implementation of Data integrity program in the relevant work area and Insure following up ALCOA principles all over operations.
- Responsibility for compliance with Viatris Quality Standards.
- Delegate for Quality Control manager in case of his absence (if needed).
- Delegate Senior Quality Control Analyst (Finished goods) in case of absence.
- Experience and Knowledge
- A minimum of five years quality control experience.
- Demonstrated success providing technical supervision including assigning tasks, scheduling.
- Experienced with Laboratory instruments and processes
- Essential Personal Qualifications
- Bachelor’s degree in Pharmacy or equivalent scientific background.
- Good command of English language
- Excellent interpersonal, communication and presentation skills
- Demonstrated ability to work independently
- Excellent documentation and technical writing skills
- Good communications skills and able to work in a team and be able to interact with various priorities
- Active, organized and planner with high attention for details
- Ability to work under stress and meet deadlines
- High observation skil

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