Technical QA Manager
Technical QA Manager (f/m/d) – GMP / SOP /Quality management / German / GI
Project: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified 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 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.
Tasks and 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
Additional Skills:
* 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 GMPcompliant production
Reference Nr.: 923406SGR
Role: Technical QA Manager
Industry: Pharma
Workplace: Basel
Pensum: 100%
Start: ASAP
Duration: unlimited
Deadline: 25.07.2024
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com. Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.
About us: ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering. We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.
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