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Senior QA Incidents Coordinator

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Senior QA Incidents Coordinator

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change

 

Sr. QA Incidents Coordinator

 

Your tasks and responsibilities:

Do you have a background in Biotech and a passion for Quality and Product Supply with experience in handling deviation and complaints? Do you like to work independently in a diverse, international and dynamic team with broad tasks? Please go ahead and apply for the Senior Quality Assurance Incidents Coordinator, who

  • Coordinates the management and oversight of discrepancies in manufacturing of bulk, intermediates, drug product, medical devices, quality control, distribution and product technical complaints
  • Assures timely investigations, resolution of issues and implementation of corrective/preventive measures using scientific principles, root cause analysis and GMP compliance requirements.
  • Participates on teams to provide highly scientific evaluation of issues intended to mitigate business and compliance risk while maintaining product supply of (bio-) pharmaceutical product with regard to safety, efficacy, strength, purity and potency.
  • Resolves production discrepancies and customer complaints as related to product release, which must take into account all manufacturing processes, quality testing and customer requirements. Must use scientific judgment to ask key questions during investigations indented to identify root cause of issues. Requires ability to think calmly under pressure and to influence team members to arrive at decisions, which may be unpopular or difficult.

Who you are:

  • Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or an equivalent combination of education and experience.
  • Minimum of 5 years of relevant experience in GMP, Biotech Manufacturing, QC.
  • General knowledge and experience in biopharmaceutical/pharmaceutical subject matter areas including: Manufacturing of bulk, intermediates and final containers; 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 leadership and interpersonal skills.
  • Excellent communication skills, good presentation and influencing skills.
  • Ability to interact and gain the support of management.
  • Ability to effectively manage multiple, complex priorities.
  • Ability to work cooperatively in teams and peer relationships.
  • Serves as a liaison with regulators, internal auditors or external clients.
  • Fluency in English is mandatory, Fluency in German an asset

 

#LI-CH

 

Location:

 

Division:

Pharmaceuticals

 

Reference Code:

47316

Zrich, CH-ZH / Basel / Zürich / Basel, CH-BS

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