Purpose:
The Quality Validation Manager oversees the Qualification and Validation (Q&V) activities in order to ensure their compliance with GMP requirements and internal standards. He/she ensures the execution of validation protocols and evaluates the effectiveness of proposed corrective actions. Furthermore, he/she participates in internal and external audit and inspections, reviews maintenance plans and coordinates quality events related to validation activities.
Duties Description:
* Defines the scope of the equipment, systems, procedures and processes covered by the qualification and validation activities and monitors the progress of the related activities.
* Monitors the completeness of all types of qualification/validation documents to ensure compliance with current regulations.
* Checks the availability of the documents required for the execution of the validation activities.
* Reviews the Site Qualification & Validation Master Plan (VMP), Sector Validation Plan (VP), Qualification Master Plan (QMP), Cleaning Validation Master Plan, Matrixing study, IQ, OQ and PQ protocols, Periodic Review, PV protocols, Validation/Verification of Analytical Methods (AMV), shipping validation master plan, certifying their adequacy, in terms of completeness, congruence and level of the required tests.
* Draws up the Plans, Protocols and Validation Reports of Cleaning Procedures (CV) and of Shipping Validation, approves production machine recipes and manages relative obsolescence, archives production systems recipes and assigns items to equipment/machines.
* Verifies and supports the validation activities carried out by external collaborators.
* Contributes to the execution of CV, IQ/OQ/PQ, process and shipping validation protocols and periodic review documentation, with review of test results and/or verifications and defines the intervention plan and the methods of execution for new checks, in order to resolve variances found.
* Contributes to the review of standard procedures related to his/her area of relevance.
* Checks the application and effectiveness of the proposed corrective actions.
* Approves the qualification and validation reports, certifying their completeness and verification of the tests/checks performed and archives qualification and validation documentation.
* Participates in internal, external audits and inspections by Regulatory Agencies.
* Reviews maintenance plans, calibration, calibration of sample instruments, filter control plans, analytical methods periodic evaluation.
* Issues machine and environment sampling plans following process deviations or invasive maintenance, collection of analytical results and management of any out-of-specification data.
* Coordinates the investigations of quality events related to his/her area of relevance.
* Coordinates the relative correction/prevention activities if present and evaluates the efficacy of CAPA.
* Evaluates change control for his/her area of relevance.
* Ensures compliance with the legal, deontological and corporate rules governing the activities under their competence.
* Collaborates in the activities and data collection needed for the revision of the Quality System and the Quality Management Review.
* Ensures compliance with laws and regulations in accordance with the provisions of the internal control model, D. Lgs. 231/01 and codes of conduct within the area of responsibility.
Education:
* Bachelor's/Master's Degree in Biotechnology, Biology, Pharmacy, Chemistry or related scientific field.
* 5 – 7 years of experience in Quality area in the Pharmaceutical/Life-science sector.
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