Quality Vacancies At Viatris Egypt

Quality Control Analyst

Key responsibilities for this role include:

• Conduct routine and non-routine analyses of in-process materials, finished goods, and stability samples in a timely manner.
• Interpret test results and compare them with established specifications and control limits.
• Conduct chemical and physical laboratory tests to perform qualitative and quantitative analyses.
• Complete documentation required to support testing activities, including data capture forms, equipment logbooks, and inventory records.
• Ensure compliance with Data Integrity principles and Good Documentation Practices (GDP) in all laboratory activities.
• Prepare technical reports, graphs, and charts to document experimental results.
• Participate in out-of-specification (OOS), out-of-trend (OOT), and laboratory failure investigations.
• Provide quality control data required for regulatory submissions, as applicable.
• Investigate and report questionable or atypical test results to the supervisor.
• Perform data entry and trend analysis activities.
• Execute activities related to process validation, cleaning validation, and instrument qualification under supervision, as applicable.
• Support the preparation and execution of SOPs, calibration protocols, validation protocols, and qualification documents (IQ, OQ, and PQ) related to laboratory activities.
• Ensure implementation of Viatris Policies and requirements applicable to laboratory operations.
• Monitor reference standards inventory and expiry status.
• Monitor inventory and expiry status of laboratory stock items, including reagents, glassware, filters, and other laboratory consumables.
• Support the review and revision of Quality Control SOPs, as assigned.
• Participate in continuous improvement initiatives, including Lean and Six Sigma projects.
• Support QC compliance activities related to Viatris Policies, internal audits, EDA actions, and data integrity requirements.

Experience and Knowledge

• Working knowledge of current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP), with particular emphasis on Quality Control operations.
• Knowledge of analytical laboratory techniques and laboratory instrumentation, including pH meters, UV-Visible spectrophotometers, High-Performance Liquid Chromatography (HPLC), and reagent preparation.
• Familiarity with laboratory investigations, data integrity requirements, and Good Documentation Practices (GDP) is preferred.
• Experience with laboratory computerized systems and electronic data management is an advantage.
• Knowledge of pharmaceutical testing requirements, specifications, and regulatory expectations is preferred.

Minimum Qualifications for this Role

• Bachelor’s degree in Pharmacy, Chemistry or Pharmaceutical Sciences.
• 1–2 years of experience in a pharmaceutical Quality Control laboratory.
• Good command of the English language, both written and spoken.
• Strong technical writing, documentation, and communication skills.
• Proficiency in Microsoft Office applications (Word, Excel, and PowerPoint).
• Strong organizational, analytical, and problem-solving skills, with the ability to work independently and effectively within a team environment.
• Ability to manage multiple priorities, work under pressure, and meet deadlines.

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Senior Quality Control Analyst

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Quality Control Manager

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:

Bachelor’s 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 pharmacist’s 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.

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