Вакансия в архиве, закрыта 3 декабря 2016
№ 29183467

Market Compliance Quality Assurance Manager

по договоренности
Москва
Полный рабочий день на территории работодателя
Опыт работы не требуется, высшее образование
Должностные обязанности:
Job Responsibilities:
Manage Suppliers/Third Party Manufacturers (TPMs) Management Program, plan and conduct Suppliers and TPMs Audits and the Quality Questionnaire Program for materials and services.
Develop and manage Quality Technical Agreements for Suppliers and TPMs.
Manage Supplier/TPM Metrics and Performance as per the management review process.
Manage complaints and associated investigations for materials and services purchased from approved TPMs/suppliers. Coordinate activities to support investigations for non-medical and medical (adverse events) complaints. Support in the Returns process.
Review and approve documentation such as Investigations, Change Control Protocols as required by TPM’s & Suppliers as applicable in a timely and effective manner to assure product release.
Provide co-ordination, support and interfaces with TPMs facilities of new product introduction and transfers to/from TPMs.
Provide training to ensure compliance with identified quality goals and standards.
Liaise with other functions regarding market compliance topics, e.g. Pharmacovigilance, Regulatory.
Требования:
Job Requirements:
Bachelor’s Degree or equivalent in life science.
At least 5 years of experience in QA Function in Pharmaceutical environment.
Comprehensive understanding of a wide range of Pharmaceutical Manufacturing including solid dosage forms, aseptically manufactured products and lyophilized products.
Extensive Knowledge of international and local quality system and compliance legislations and standards.
Ability to communicate effectively, both orally and in writing for both technical and non-technical audience.
Strong Supplier/Third Party Manufacturing expertise.
Teamwork attitude and capability of understanding and overcoming different cultural and language obstacles to provide solutions satisfying corporate, divisional and local objectives.
Ability to use Quality Risk Assessment and Root Cause Analysis tools.
Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
Detailed knowledge of inspection and auditing standards.
English language knowledge at least at Intermediate level.
Мы предлагаем:
We offer:
Work with a highly professional team
Good benefit package
Opportunity of professional and career growth
Medical and life insurance
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