Technical QA Manager

m/f/d, Basel-Stadt

You will support 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.

You will be reponsible for running, maintaining and continuously improving Qualification/Validation activities including Computerized System Validation (CSV) as well as QS (quality systems) within IMP Quality Operation Switzerland.

Start date: As soon as possible

Duration: 1 year/possible extension

Workload: 100%

Location: Basel, on-site

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 Base
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
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

Requirements:

Degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
Fluent German is mandatory
Min. 5 years of Quality Management related experience in the Pharmaceutical industr
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

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