Quality Associate External quality in Baar

veröffentlicht
Kontakt
Olivier Worch, Basel Professionals Health Care & Life Sciences
Jobtyp
Temporär
jetzt bewerben

job details

veröffentlicht
Ort
Baar, Zug
Sektor
Life Sciences
Jobtyp
Temporär
Referenznummer
13365
Kontakt
Olivier Worch, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50

Stellenbeschreibung

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.

 

Responsibilities:

  • 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

 

Requirements: 

  • A minimum of 3 years of experience in similar position 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

 

olivier.worch@randstad.ch

I am looking forward to receiving your applications

 

Olivier Worch