Position: Mid-Senior level

Job type: Full-time

Loading ...

Job content

Job Title: Local Quality OwnerJob Function: QualityJob Sub functione: Quality (Generalist)Duration: 18/04/2023 to 31/12/2023 (Likely to be extended)FTE/volume in %: 100Position SummaryWe are seeking a Local Quality Owner to oversee quality assurance (QA) for selected parenteral products manufactured at our clients site. As the Local Quality Owner, you will be responsible for ensuring the quality oversight of all relevant activities in sterile fill and finish, assembly, and packaging of the respective combination products (if applicable). The successful candidate will play a key role in ensuring that our products meet regulatory guidelines and quality standards.Main Responsibilities
  • Ensure on-time release of parenteral products, including intermediate and finished products
  • Proactively mitigate risks to ensure quality standards are met
  • Lead investigations for major non-conformance’s (deviations)
  • Review and approve non-conformances (deviations) records and change control requests
  • Review and approve GMP critical SAP master data, such as bill of materials, manufacturing instructions, etc.
  • Review and approve work instructions and standard operating procedures
  • Issue and review Quality Agreements
  • Provide support for projects and customers (production, logistics, engineering, etc.) in terms of GMP compliance
  • Review Product Quality Reviews
Your ProfileThe successful candidate for this position will have the following qualifications:
  • Master’s degree in a technical or science discipline
  • Five to ten years of experience in a GMP regulated Pharma production environment or five years of experience in a relevant quality role
  • Strong background in regulatory guidelines preferred
  • Knowledge in aseptic processing preferred
  • Experience as a team or project lead preferred
  • Advanced communication skills in German and English (oral and written)
In addition, you should be a team-oriented, dynamic, and highly motivated individual with strong communication skills.Collaboration with different departments will require flexibility, social competence, and a reasonable degree of authority. You will be expected to make independent decisions and provide advice as needed.Education RequiredUniversity/Bachelor’s degree or equivalentWork ExperienceGenerally requires 6-8 years of work experience in a relevant field.If you meet the qualifications listed above and are looking for an exciting new opportunity, we encourage you to apply for the Local Quality Owner. We look forward to hearing from you!For a confidential discussion about this role, or to apply, then send your CV to r.haider@nonstopconsulting.com or call me, Rashed Haider, Search Specialist - Life Sciences - Switzerland, at +41 435 080 817 (intern 3240). Please feel free to visit my Linked-in profile to see my references/recommendations.NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Switzerland.
Loading ...
Loading ...

Deadline: 07-04-2024

Click to apply for free candidate

Apply

Loading ...
Loading ...

SIMILAR JOBS

Loading ...
Loading ...