For a big pharmaceutical company in Basel we are looking for a

Technical QA Manager

Background:

The IMP Quality Operations Unit Switzerland in Global Technical Operations is the Quality partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and GMP-compliance oversight of all Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland.

The perfect candidate:

The perfect candidate is someone with an academical natural science background and 10+ years of experience in the pharmaceutical industry, ideally 5 years in QA. The candidate also brings a broad experience in Qualification/Validation and CSV of Small Molecules, Analytics and/or Biologics and a deep technical understanding of pharmaceutical production.

General Information:

• Start date: asap

• Planned duration: 1 year

• Extension: very likely

• Workplace: Basel

• Workload: 100%

• Home Office: Onsite required, home office upon discussion

Tasks and Responsibilities:

• The candidate supports the 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. The main responsibilities are:

• QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within TR&D in Basel

• 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.)

• Assist management in regulatory inspections and performing internal as well as partner audits. Ensure adherence to cGMP requirements and policies and standards in technical development functions

• Apply advanced theory, quality principles, expert judgment and cross functional expertise to address complex problems independently

• Creation and periodic review of quality agreements (QAGs) with contract organizations including quality agreements between our client company's sites

• 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 and CSV of Small Molecules, Analytics and/or Biologics ****

• 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

For more information please contact