The QC Validation Specialist, Validation Operation Services performs validation and qualification activities for the QC equipment. They assure compliance of these activities with cGMP as well as with internal policies and procedures.

The QC Validation Specialist is authorized to direct external vendors performing work in this field.

Additional responsibilities are:

• Writing Technical Working Instructions for QC equipment (version 1 only). The update of the Technical Working Instructions remains the responsibility of QC department. This position cannot be involved in any others functions present in QC department.
• Involve for qualification of others equipment present in production, warehouse, facilities, equipment, utilities and computer system validation as backup for other members of the Validation team.

Experience / Education  

• Federal Certificate of Capacity as Laboratory Technician or similar education
• Experience in pharmaceutical qualification and validation; at a solid dosage plant is advantageous

Knowledge / Skills / Abilities:

• Knowledge in QC equipment as HPLC, GC, dissolution, UV, IR
• Experience of doing qualification according to Ph. Eur, USP and JP Pharmacopoeia
• Experience in laboratory equipment qualification
• Familiarity with current international regulatory regulations, cGxP requirements and best practises, including 21 CFR part 11, 210 and 211, Annex 11n, EU-GMP guidelines and GAMP
• Excellent team spirit
• Good communication skills in English with facility, production, laboratory, technical operations, QA, and outside vendor groups; French advantageous
• Good knowledge and/or ability to familiarize themselves with new software and computerized systems (specific instrument software, LIMS)
• Team player: ability to interact effectively with team and customers

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management

• Responsible to ensure QC equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
• Responsible for validation project documentation, including author and when required review qualification and validation documentation, including risk assessments, specification documentation, validation plans, protocols, reports, traceability matrix and summary reports, and ensuring on time approval.
• Responsible for the execution of qualifications for all equipment and systems across the site, including production, warehouse, facilities, equipment, utilities and computer system validation, excluding global IT systems.
• Responsible for the first version of Technical Working Instructions for QC equipment (including author, send to review/approval)
• Support the execution of validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes.
• Participate to the development and maintenance of the local site procedures
• Participate to risk assessments and risk management teams
• Responsible to review change controls / SCF (System Classification Form) documents to evaluate impact on qualified systems and validated processes
• Responsible to develop and justify the validation approach based on risk and a scientific rational
• Responsible to co-ordinate qualification and validation execution activities, including external vendors and internal departments