Technical QA Manager
For our client, an international pharma company in Basel, we are looking for a Technical QA Manager to join the IMP Quality Operations Unit Switzerland in Global Technical Operations.
The perfect candidate is someone with an academical natural science background and 10+ years of experience in the pharmaceutical industry and 5 years in QA. The candidate also brings a broad experience in Qualification/Validation of Synthetic Molecules and a deep technical understanding of pharmaceutical production. Experiences in Biotech production and Analytics is a plus.
General Information:
- Start date: ASAP
- Planned duration: 1 year
- Extension: very likely
- Workplace: Basel
- Workload: 100%
- Home Office: upon discussion
- Working hours: Standard
Tasks & Responsibilities:
- Support of end to end cGMP activities, in maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products.
- QA supervision of qualification- and validation-activities for GMP-relevant equipment for Synthetic Molecule production and Biotech production
- Responsible to ensure QA oversight and setting guardrails for the operation facilities regarding GMP and Quality standards
- Support of implementation of DI requirements
- Provide sound technical and quality assurance expertise for review and approval of quality related documents (e.g. Deviation records, CAPAs, SOPs, Risk Analysis etc.)
- Performing deep root cause analyses as a facilitator or expert to address and investigate complex problems independently
- Responsible for driving and optimization activities and improvements within IMP Quality Operations Switzerland
- Partner with stakeholders and provide guidance to ensure successful delivery of the IMP goals
- Represent and support your area of responsibility at HA inspections and internal audits
Must Haves:
- Academical degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
- Min. 10 years experience in the pharmaceutical industry with 5 years of Quality Management related experience in the pharmaceutical industry
- Experience in Qualification/Validation of Small Molecules, in addition of Biotech Molecules
- Sound understanding on current DI (Data Integrity) requirements
- Profound knowledge of global quality and GMP requirements
- Strong team-player with a high level of self-motivation and the ability to effectively influence others across all levels of the organization
- Successful performance in health authority inspections and internal GMP audits
- Fluent German and English (spoken/written) is a must for this position
- Great communicator to stakeholders and in the team
- “Can-Do” attitude and self-confident to take over new responsibilities and tasks
- Ability to speak up, listening to other opinions and able to rethink the own way to ensure a highest level of success
- Knowledge of Pharmaceutical Development and about the special needs and road blocks regarding GMP-compliant production
For our client, an international pharma company in Basel, we are looking for a Technical QA Manager to join the IMP Quality Operations Unit Switzerland in Global Technical Operations.
The perfect candidate is someone with an academical natural science background and 10+ years of experience in the pharmaceutical industry and 5 years in QA. The candidate also brings a broad experience in Qualification/Validation of Synthetic Molecules and a deep technical understanding of pharmaceutical production. Experiences in Biotech production and Analytics is a plus.
General Information:
- Start date: ASAP
- Planned duration: 1 year
- Extension: very likely
- Workplace: Basel
- Workload: 100%
- Home Office: upon discussion
- Working hours: Standard
Tasks & Responsibilities:
- Support of end to end cGMP activities, in maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products.
- QA supervision of qualification- and validation-activities for GMP-relevant equipment for Synthetic Molecule production and Biotech production
- Responsible to ensure QA oversight and setting guardrails for the operation facilities regarding GMP and Quality standards
- Support of implementation of DI requirements
- Provide sound technical and quality assurance expertise for review and approval of quality related documents (e.g. Deviation records, CAPAs, SOPs, Risk Analysis etc.)
- Performing deep root cause analyses as a facilitator or expert to address and investigate complex problems independently
- Responsible for driving and optimization activities and improvements within IMP Quality Operations Switzerland
- Partner with stakeholders and provide guidance to ensure successful delivery of the IMP goals
- Represent and support your area of responsibility at HA inspections and internal audits
Must Haves:
- Academical degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
- Min. 10 years experience in the pharmaceutical industry with 5 years of Quality Management related experience in the pharmaceutical industry
- Experience in Qualification/Validation of Small Molecules, in addition of Biotech Molecules
- Sound understanding on current DI (Data Integrity) requirements
- Profound knowledge of global quality and GMP requirements
- Strong team-player with a high level of self-motivation and the ability to effectively influence others across all levels of the organization
- Successful performance in health authority inspections and internal GMP audits
- Fluent German and English (spoken/written) is a must for this position
- Great communicator to stakeholders and in the team
- “Can-Do” attitude and self-confident to take over new responsibilities and tasks
- Ability to speak up, listening to other opinions and able to rethink the own way to ensure a highest level of success
- Knowledge of Pharmaceutical Development and about the special needs and road blocks regarding GMP-compliant production
- +41 58 201 55 50
- Basel Professionals IT & Life Sciences
