Posted on Oct 5, 2019 by Harvey Nash IT Recruitment Switzerland
For our client in Stein we are looking for Compliance Expert for 14-month contract.
Job title: Compliance Expert
Duration: 01/11/2019 to 31/12/2020
Principle role is to manage the general/systematic quality assurance (QA) activities within the solids manufacturing process units to meet the needs of the business, ensuring compliance with the required documentation and quality system's needs. To ensure compliance of products, validations/qualifications and assigned change control projects from initiation to execution, in order to ensure timely supply to the markets in compliance with regulatory and current Good Manufacturing Practice (cGMP) requirements as well as Companys internal quality standards. Review and approve GMP-documents associated with all related activities.
. Compile Annual Product Reviews (APRs)/Product Quality Reviews (PQRs) in accordance with GMP-requirements. Ensure that related follow-up activities are defined, carried out and reported.
. Responsible for the APQR planning, for the new project on new tool.
. Lead the evaluation and implementation phases of change requests, considering the most effective implementation strategy, priorities and regulatory requirements. Ensure GMP-compliant documentation, evaluation and implementation of changes. Proactively lead and follow up changes with all involved partners.
. Maintain and ensure general QA-oversight of all activities of the related Process Units (PUs) (with regard to products and general Quality Systems) and ensure general GMP-Compliance.
. Review and approve Master Batch Records, Standard Operating Procedures (SOPs), Transfer Protocols, Reports and other GMP-relevant documents.
. Lead, oversight and participate in self-inspections, and support inspections from health authorities on site.
. Initiate and implement quality improvement projects, conduct QA walkthroughs...etc
. Actual agreed upon Key Performance Indicators (KPIs) eg number of APR/PQRs, documents reviewed/prepared in time, change requests processed in time and in required quality, self-inspections, reporting etc.
. No issues or critical deviations triggered by information and documents provided, no issues and inspection findings due to non-adherence to cGMP, Health, Safety and Environment (HSE) regulations and SOPs
. Inspections (by Health Authorities, customers, GCA) are diligently prepared, accompanied and followed-up.
. The individual achievement is evaluated through the performance dialog Performance Management Process (PMP)
* Education: (Technical) University/academy degree in chemistry, pharmacy or equivalent
. German (fluently spoken/written); English very good knowledge (spoken written
. Experience: Professional experience in quality control/quality assurance or in the manufacturing of pharmaceutical drug products.
* Profound knowledge in cGMPs
For further details please contact: