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QA Operations Manager
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Biotechnology and Pharmaceutical organization, based in Basel-Stadt Switzerland.
This is a role at the European HQ of our client.
Provides CMO oversight, ensures QA operational activities and preparation for release of Drug Substance and Drug Product.
- Ensures and performs QA operational activities, such as review of manufacturing batch records, release documentation of batches associated with Drug Product and Drug Substance.
- Identifies and reviews production discrepancies as related to product review / release, which must take into account all manufacturing processes, quality testing and customer requirements. Must use scientific judgment to ask key questions during investigations intended to identify root cause of issues.
- Understands technical and release problems and evaluate their potential impact on product quality.
- Participates in cross functional teams providing scientific evaluation of issues intended to mitigate business and compliance risk while maintaining product supply of products with regard to strength, purity, and potency.
- May perform CMO site visits for batch record review and PIP activities.
- Reviews and maintains production related records, and deviation records as needed.
- Contribute to Product Change Control coordination and review.
- Support the preparation and the review of the APR/PQR in collaboration with the respective Product Quality Manager.
- Provides basic tracking and trending analysis relevant to business process.
- Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education
- Minimum of 2 years of relevant experience
- General knowledge and experience in biopharmaceutical subject
- Matter areas including: Manufacturing of Drug Substance and Drug
- Product; Product disposition and release; Discrepancy management;
- Product inspection and labeling; Aseptic processing; Environmental monitoring; Contract manufacturing
- General cGMP experience and knowledge, QA/QC and regulatory compliance (US and other international agencies)
- Must be able to make tough decisions under pressure and be able to adapt to changes in organization structure
- Good interpersonal skills
- Good communication skills, good presentation and influencing skills
- Ability to effectively manage multiple, moderate - complex priorities
- Ability to work cooperatively in teams and peer relationships
- Serves as a liaison with regulators, internal auditors or external clients
- Proficiency in spoken and written English language
- Proficiency in Microsoft Office applications
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.