Quality Control Manager

Job Summary

Viatris Egypt S.A.E

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life we provide access at scale currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of lifes moments from birth to the end of life acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day we rise to the challenge to make a difference and heres how the Quality Control Manager role will make an impact:

Key responsibilities for this role include:

• Responsible for the QC laboratory functions (Chemical Stability Methodology Raw material Packaging & Microbiology) and the corresponding documentation to support the timely disposition of products and materials
• The laboratory function encompasses raw material packaging Stability finished product testing method validation and QC Compliance.
• Manage the overall Quality control release and disposition of incoming materials and finished products.
• Performing routine Gemba walks in QC Labs to ensure GMP and safety practices are strictly followed
• Review and approval of Laboratory out-of-specification and failure investigations
• Support regulatory inspections and audits and address findings
• Track and evaluate Quality Control KPIs identifying trends and leading improvement initiatives to enhance performance and compliance and present to Quality Council
• Review and approval of the entire SOPs relating to Quality control tasks and ensure understanding and implementation of these SOPs.
• Responsible for closing the gaps between Viatris Quality Policies regulatory requirements and compliance practices.
• Responsible for ensuring implementation and sustaining QC data integrity program and ALCOA on laboratory level and ensure data integrity implementation throughout lab operations
• Support laboratory colleagues in all aspects of their work to achieve the completion of tests and/or investigations in a timely manner as well as maintaining an updated knowledge base in the technical operations company policy and regulatory fields.
• Facilitate continuous improvement in QC day-to-day operations and general systems and will actively support achievement of site goals.
• Responsible for QC resource planning including preparation of budgets and monitoring budget adherence with QO manager.
• Coaching and developing QC colleagues to achieve high performance.
• Implementation of Viatris Operational Excellence standards and facilitating PHE (Production Health Evaluation) HEP (Human Error Performance) and Continuous Improvement Projects
• Ensuring compliance with Pharmacopeial requirements and up to date with Pharmacopeial notifications and updates
• Leading and guiding QC inspection readiness
• Review and approve the protocol and the results of the Analytical Method Transfer Exercise (AMTE) locally (for the new analysts) and for other locations. Also responsible for receiving and implementing AMTE for the new product manufacturing.
• Ensure implementation of all the stability (Ongoing and Accelerating stability) programs including review and approval of the stability reports.
• Review and Approve the Validation of new developed test procedures.
• Review and Approve the Validation protocols and reports
• Preparing and ensuring the execution of the development plan (IDP) for QC colleagues
• Encourage the QC members in applying RFT projects for M1 M2 and M3 and follow up these projects.
• Ensure that safety guidelines are implemented and followed in QC lab
• Active implementation of Critical Quality Notifications and Notification to Management procedures.
• Delegate for Site Quality Operation Head in case of his/her absence (if needed).
• Delegating Finished goods Section Head Microbiology Section Head Raw Materials Section Head QC Compliance Section Head or Quality Control Section Head (Stability and Methodology) in case of absence.
• Being eligible to be registered as QC Manager according to EDA requirements and legislation

The minimum qualifications for this role are:

• Bachelors degree in Pharmaceutical Sciences is a must
• Minimum 10 years experience in QC lab operations
• cGMP & cGLP Extensive Knowledge
• Data Integrity and ALCOA Knowledge
• Good understanding of the pharmaceutical regulatory process.
• Complying with EDA legislation for QC Manager registration

The following documents to be available:

• Experience letter(s) for 10 years of relevant experience in QC
• Original certificate confirming the pharmacists position regarding mandatory assignment (Taklif)
• Valid Pharmacy Syndicate Membership Card

The essential personal qualifications for this role are:

• Six Sigma Knowledge and Green Belt holder is a plus.
• Good command of English both written and spoken.
• Excellent problem-solving and investigative skills
• Experience in handling regulatory audits and inspections
• Logical thinking.
• Management and decision-making skills.
• High analytical skills.
• Communication & high interpersonal skills.
• Good planning skills.
• Time Management skills.

At Viatris we offercompetitivesalaries benefitsandan inclusive environment where you can use your experiences perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.