Technical QA Manager (m/f/d)
Technical QA Manager (m/f/d) – Quality Management / Qualification/Validation / CSV of Small Molecules / Data Integrity / GMP/IMP/ English & German
Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Technical QA Manager (m/f/d).
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 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:
* Running, maintaining and continuously improving Qualification/Validation activities including Computerized System Validation (CSV) as well as QS (quality systems) within IMP Quality Operation Switzerland
* Support and drive implementation of global Roche standards and requirements as defined in the PQS within IMP Switzerland.
* Responsible for driving and optimization activities and improvements within IMP Quality Operations Switzerland
* Support and collaborate with Quality Assurance Managers within IMP Quality Operations Switzerland PTQDF
* Provide sound technical and quality assurance expertise for review and approval of quality related documents (e.g. SOP maintenance and administration)
* 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
The perfect candidate:
The perfect candidate is someone with at least 5 years of experience in QA, with a first experience in Qualification/Validation and CSV of Small Molecules, Analytics and/or Biologics.
Tasks & Responsibilities:
* 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
* Review and approval of GMP relevant Documents like Plans, Reports, SOPs, Change Control, Discrepancy Management, CAPA (corrective action and preventive action), Risk Analysis
* Assist management in regulatory inspections and performing internal as well as partner audits Ensure adherence to cGMP requirements and Roche policies and standards in technical development functions
* Apply advanced theory, quality principles, expert judgment and cross functional expertise to address complex problems independently
* Provide technical and quality assurance input to review and approval of manufacturing and Quality related documents as appropriate, Serve as a Subject Matter Expert (SME) in support of departmental functions and build partnerships and collaborate with stakeholders in other areas of the business to ensure success of the quality.
* Leading of complex risk assessments Leading resolutions of quality issues and establish work priorities to meet targets and timelines
* Creation and periodic review of quality agreements (QAGs) with contract organizations including quality agreements between Roche sites.
* Cost conscious working and optimization of processes. Ensure the efficient use of the available resources (staff, equipment, machinery, working spaces, materials).
* Assistance is required in the introduction and training of new employees
Must Haves:
* Degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent.
* Min. 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
* Experience with MES (Manufacturing Execution System)
* Profound knowledge of global quality and GMP requirements and a detailed understanding of current industrial trends in IMP
* Proven ability to work towards results, excellent planning and organizing skills in order to manage multiple tasks at the same time as well as analytical capabilities and an innovative manner of solving problems
* High expertise and experience in building and maintaining constructive and effective relationships with internal and external partners and stakeholders
* Strong team-player with a high level of self-motivation and being able to inspire others
* Ability to effectively influence others across all levels of the organization
* Strong collaboration across cultures, countries, technical competencies, and organizational levels
* Successful performance in health authority inspections and internal GMP audits
* Fluent German and English (spoken/written) is a must for this position.
Reference Nr.: 923406SDA
Role: Technical QA Manager (m/f/d)
Industrie: Pharma
Workplace: Basel
Pensum: : 100% (Onsite required, home office upon discussion)
Start : ASAP
Duration: 12 ++
Deadline: 02.06.2024
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.
