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International QA role Biopharmaceuticals

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Come on board for one of the most successful biopharmaceutical companies worldwide. Our customer has an extensive product portfolio, which includes various biotechnologically manufactured active…

International QA role Biopharmaceuticals
Come on board for one of the most successful biopharmaceutical companies worldwide. Our customer has an extensive product portfolio, which includes various biotechnologically manufactured active pharmaceutical substances (drug substance) and various galenical technologies for drug product, especially Steriles. Growing volumes result in an increased complexity of the processes.
We offer an exciting QA role, in which you will have oversight on diverse external partners and CMOs. You support the high GMP level of the manufacturing documentation and assure compliance international regulatory standards for biologics drug substance and drug product manufacturing. You will ensure compliance with QC testing standards, SOPs, validation guidelines and regulatory filings. You author, compile and maintain documentation, review relevant documentation and recommend disposition, escalate potential issues. Your input is required for complaint management, change control and CAPA procedures.You will also prepare and review of Quality Agreements with external partners and assist in PQR writing necessary for end to end product monitoring. Your analytical knowledge will be required for reviewing analytical and method protocols, supporting method test transfer and revision documentation. You provide quality support during self-inspections, internal audits, and regulatory agency inspections at contract manufacturers. You will establish strong relationships with the Quality stakeholder and Senior Management both internally, with partner companies and CMOs.Your profile:
  • B.Sc, M.Sc, PhD in Life Sciences
  • 3-5 years of experience in Pharma - Biotech Operations
  • 1-2 years in a QA role (also QC, QualVal or similar is valid)
  • Hands-on experience on manufacturing site, preference on steriles

Strong interpersonal communication, collaborative and leadership skills in dealing with a broad variety of cultures. You have demonstrated the ability in technical writing are able to work in a matrix organization in virtual international environment. Act as a quality influencer throughout all steps in the multi-site supply network and show your talent in building trustful and effective relationships

Interested? We are looking forward to get in touch with you.

Adresse

gloor & lang ag life science careers
Herr Luca Rohr
Associate Consultant
Bahnhofstrasse 31
5400 Baden
+41 61 206 61 81

E-Mail

Website http://www.gloorlang.com

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