Internship PQV42] (QXW753) – DI-079 | FUE-047) | KP427) MQL50 – Global Product Quality Manager | (DG-23) W
Job Description
DI-079 | FUE-047) | KP427) MQL50 – Global Product Quality Manager | (DG-23) W
DI-079 | FUE-047) | KP427) MQL50 – Global Product Quality Manager | (DG-23)
DI-079 | FUE-047) | KP427) MQL50 – Global Product Quality Manager | (DG-23)
MQL50 – Global Product Quality Manager | (DG-23)
MQL50 – Global Product Quality Manager | (DG-23)
domainGrunenthal location_onSantiago
What the job looks like: Ensure regulatory CMC compliance of all supervised medicinal products with national and international guidelines/regulations and with the relevant Marketing Authorizations in order to gain and/or maintain registrations Providing critical assessment and strategic input, flagging risks, proposing mitigations as well as highlighting opportunities for Grnenthal for the quality part of dossiers to maximize chances of success for approval. Issue and provide regulatory CMC documentation, Active Substance Master Files (ASMFs) and CMC documentation (Module 3 and 2.3), timely and in due form by considering current and relevant guidelines to support obtainment and maintenance of national and international regulatory registrations. Preparation of responses to pharmaceutical questions from Authorities (e.g. deficiency letters, requests) Support in maintaining respectively obtaining Certificates of Suitability (CEPs) and Marketing Authorizations (MAs) for APIs respectively medicinal products Responsible for interacting with stakeholders from e.g. Regulatory Affairs, Supply Chain, Production, Quality control and other key functions, and representing GQA CMC in cross functional teams Ensure product-related regulatory CMC support for Affiliates, License Partners and Third Parties Collaborate with the manufacturing site in order to give QA support to maintain regulatory compliance of the manufacturing processes and to ensure regulatory compliance of all changes to the processes.
Responsibility for the coordination, regulatory evaluation and implementation of product-related changes. QA-CMC support in preparation of Technical Agreements with contract manufacturers, other manufacturing site, Affiliates, and Suppliers (e.g API) in order to assure regulatory compliance. Involved in review of available manufacturing instructions, stability protocols, test instructions and validation protocols for products manufactured in-house and by contract manufacturers (as laid down in respective agreements) with regard to regulatory compliance.
Support in preparation of Product Quality Reviews QA-CMC regulatory support of product transfers. Review of relevant documentation, e.g. transfer documents and testing documentation to ensure regulatory compliance. QA-CMC support of the manufacturing site and CMOs concerning Change Control System in order to assure regulatory CMC compliance Supporting due diligence and partnering activities as assigned
Take-over of project-orientated special tasks in accordance with instructions by Head CMC Compliance Internal Manufacturing LatAm. What you’ll bring to the table: Professional experience: At least 3 years experience in lifecycle Regulatory CMC preferably for NCEs, Biologicals and knowledge on Medical devices (Drug product combinations)Sound experience in GMP environment Educational background: Grade as pharmacist or other natural science (e.g. chemist, biologist)Ph. D. in Natural Science (not mandatory)Personal skills & competences: Self-dependent and independent way of workingExcellent team working Global and service-oriented mind-set, strong sense of cultural/diverse backgrounds Excellent interpersonal, oral and written communication skills and abilities, positive attitude Decision making capabilities, also in difficult situations Accommodative and flexible way of working
Best Understanding of Continuous Improvement and Process ExcellenceGood English knowledge in writing and communication plus other language preferably Spanish or German
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domain INACAP
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trending_up CLP 60.000.000 – 80.000.000
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location_on Santiago
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domain Meds
location_on Santiago
trending_up CLP 40.000.000 – 60.000.000
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Kit Empleo
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