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CSV Manager - Coopers Group GmbH - HELP

For our Pharma client in Basel, we are looking for a CSV Manager

Start date: 06.01.2020
Duration: till 31.03.2020 (+ possible extension)
Location: Basel (50% remote work possible)

The Computer Systems Quality Assurance Team is ensuring, that all global GMP computer systems are compliantly delivered and maintained. In addition, the team is establishing quality standards that support pharmaceutical manufacturing, testing and releasing processes.

This open position will be for a QA manager to perform tasks around Computer Systems Validation of global computerized systems. The position is located in Basel.

Tasks & Responsibilities

Perform quality assurance tasks regarding validation of global computerized systems according to the GMP Inventory and regarding projects (ie PT strategic projects and smaller projects).
Align quality assurance tasks across the organization within the department as well as with other global or local functions.
Provide guidance for local quality departments.
Assure compliance of systems according to the GMP Inventory by providing templates, support in creation of CSV documentation, review and approval of SOPs.
Support Quality Assurance tasks regarding validation of computerized systems, including review and approval of validation life cycle documents, review and approval of validation reports and release systems according to CSV, approval of change requests and owning discrepancies.
Support interpretation of the internal Policy and Directives as well as external guidelines

Must Haves

8 to 10 years of relevant experience in the pharmaceutical or biopharmaceutical industry with sound knowledge of cGMPs or equivalent regulations as well as demonstrated expertise with computer system validation and risk management, change control, and discrepancy/CAPA management (most important requirement) (*)
Experience in working in validated or controlled environments and ability to propose pragmatic quality approaches while maintaining full compliance to regulations and standard
Knowledge of manufacturing, cGMP's and compliance
Proven experience working with SAP/ERP/Serialization Systems
Experience working with HP ALM
High quality orientation with attention to detail; drives for excellence and positive business outcomes
Excellent collaborator with proven ability to work well with others in a proactive, positive and constructive manner
Strong self-motivator who can manage multiple priorities
Demonstrated influencing and interpersonal skills with strong written and verbal communication skills; ability to communicate effectively with all levels of the organization
Fluent in English