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Emploi: quality associate external

Job description:

job details

   . 09. octobre 2019
   . baar, zoug
   . life sciences
type d'emploi
   . temporaire
   . 13365
   . olivier worch, bâle professionals health care & life sciences
   . 058 201 55 50
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description du poste

Randstad Professionals is currently looking for a Quality Assurance Associate (focus on Global external Quality) who will be assigned an interesting challenge for a major client based close to Zug (central Switzerland).
This contract is a great opportunity to join a global group focusing on the Biotech sector. The initial assignment will start immediately and will last until April 2020.
Contract details:
Start Date:   ASAP
Requisition End Date:   April 2020
Assignment overview
The main purpose of this job is to manage the QA interface with manufacturing and testing partners for commercial biosimilar finished products by ensuring quality of product / process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements.
The responsibilities also include the evaluation of the general performance of contractors and the identification, negotiation, implementation and follow-up of process and systems improvements, as well as the organization and conduct of quality management reviews with contract manufacturing organizations (CMO). The role also includes quality management of the product lifecycle management in relation with contract manufacturing, and support to CMC functions such as review and approval of regulatory filings.
Manage the QA interface with manufacturing and testing partners for commercial biosimilar finished products and ensure quality issues are appropriately investigated, tracked and resolved in a timely manner.
Assure the timely and appropriate investigation, impact assessment, close out of deviations and investigations involving partners and contractors. Ensure appropriate corrective and preventive actions are defined, implemented and that their efficacy is evaluated.
Perform quality review and approval for change requests with impact to contract manufacturing or related supply chain operations, ensuring that appropriate internal and external stakeholders’ feedback is collected and taken into consideration, as well as ensuring compliance with applicable regulations and desired product characteristics and specifications.
Responsible for quality aspects related to the transfer or set-up of processes related to commercial biosimilar finished products to all contract manufacturing organisations under the responsibility of Biogen Idec International, including but not limited to risk assessments, validations protocols and reports review and approval, defining and following up on quality and performance indicators
Prepare, manage and maintain quality agreements with manufacturing and partners for commercial product
Review and approve regulatory files prior to submission, for area of competence
Perform trend analyses based on indicators as well as feedback from other department (for example Release, Contract Manufacturing) and take actions as adequate. Perform the periodical evaluation of the performance of contract manufacturing organisations in collaboration with other concerned departments.
Responsible for the preparation of CMOs and internal departments to regulatory inspections.
Participate in regulatory inspections and support regulatory inspections at CMOs. Perform risk assessments as preventive measures or in response to product/ quality system failures, investigations and regulatory inspections
A minimum of 3 years of experience in similar situation in pharmaceutical or biotechnology industries
Relevant experience in either manufacturing, development, quality or regulatory;
Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies’ regulations is a plus);
Knowledge of medical device regulations and manufacturing is a plus
If you are interested to learn more about this great opportunity, don’t hesitate to get in touch with me. Feel free to send me your CV at following email
I am looking forward to receiving your applications
Olivier Worch


Job Category: Legal [ View All Legal Jobs ]
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Salary: Unspecified
Degree: Unspecified
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Job Location: autre
Company Type Employer
Post Date: 10/09/2019 / Viewed 25 times
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