QC Section Head At Viatris Egypt
Responsible for the QC laboratory functions (Stability & Methodology) and the corresponding documentation to support the timely disposition of product.
Job Specific technical/Functional/Professional Competencies:
Responsible for the QC laboratory functions (Stability, & method validation) and the corresponding documentation to support the timely disposition of product.
Responsible for ensuring that all results generated are in compliance with data integrity requirements.
Responsible for raising “NTM” Notification to Management whenever conditions apply.
Responsible for fulfilling all regulatory requirements related to stability and methodology.
Review and approval of the entire SOP’s relating to Stability and methodology and ensure understanding and implementation of these SOP’s and for closing the Gaps between Viatris policies and QC (stability and methodology) and compliance practices.
Establish, recommend, maintain, and assure that consistent laboratory procedures and practices are followed in accordance with company policy and regulatory requirements.
Troubleshooting of the stability & methodology section problems.
Coaching and developing stability and methodology colleagues to achieving high performance and ensuring the execution of the development plan (IDP) and encourage the QC members to perform.
Review and approve stability out-of-specification and failure investigations and ensure that all steps are completed within their time frame.
Responsible for QC release for batches held for stability and back up for finished goods QC approval and release.
Supporting outsource manufacturing department, for evaluation of stability studies of outsourced products, and troubleshooting any problems concerning analysis and stability of outsourced products and conducting stability oversight in the outsourced stability laboratory when applicable.
Responsible for the stability studies of finished products and corresponding documentation to evaluate/support shelf life of product, Reviewing and approval of stability schedule, reports, and trends.
Responsible for stability equipment calibration & maintenance.
Maintains laboratory supplies inventory required for Stability analysis.
Responsible for handling the global changes affecting stability and methodology.
Responsible for receiving and assessment of compendial updates and ensure the compliance of Viatris internal documents with the latest compendia.
Supports QA with all CCRs and QARs related Stability & Methodology.
Responsible for fulfilling all method validation requirements, review, and Approval the Validation of new developed test procedures and method Validation protocols.
Responsibility for implementation of Data integrity program in the relevant work area and ensure following up ALCOA principles all over operations.
Active implementation of Notification to Management procedures.
Responsible for compliance with Viatris Quality Standards.
Act as a delegate for Quality Control Manager in case of his/her absence (if needed).
Delegate Senior Quality Control Analyst (Stability and Methodology) in case of his/her absence.
The minimum qualifications for this role are:
Bachelor’s degree in pharmacy or science.
5 - 7 years’ experience in a related area.
Green belt holder is a plus.
Good command of English in both written and spoken.
Excellent in Microsoft office (word, excel & PowerPoint)
Knowledgeable with interpersonal, good communication and presentation skills.
cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.
Strong knowledge with Laboratory instruments mainly chromatographic data systems.
Good understanding of the pharmaceutical regulatory process and EDA stability and AMV guidelines.
Ability to interact with various priorities with good communication with stakeholders.
Demonstrated ability to work independently.
Must be able to work in a stressful, on-demand environment and be able to communicate under stress in a non-confrontational, effective manner.
Excellent documentation and technical writing skills.
High observation, analytical, problem solving and good planning skills.
Scientific and logical way of thinking.
Time management, people management and decision-making skills.
Active and organized with high attention to detail.
Hard worker and self-motivated.
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