Reporting into the Laboratory Supervisor CoE or associate Director Quality Assurance the Associate Specialist - Quality Control/Assurance Compliance will be responsible for the management of QC/QA deviations and CAPA's, QC/QA GMP changes, Excel spreadsheets and validation. He/ she will be responsible for compendia changes implementation and for providing GMP support to the QC/QA organization by coordinating GMP compliance related projects.
As part of the role the Specialist- Quality Control/Assurance Compliance will also be responsible for:
Quality Control/Quality Assurance
- Performs QC/QA investigations, impact assessment (product, process, validation, etc.), Root Cause Analysis (RCA), investigation protocols and reports related to deviations;
- Responsible for management of QC/QA changes and deviations (such as analytical procedures and changes/deviations within operations) including writing and updating documents and associated analysis data sheets according to MMD-GCM. Responsible for the validation of Excel sheets (conform SDLC) and is responsible for the coordination, documentation and transfer tests;
- Documentation coordination and administration related to QN's, CAPA's and QC/Qa projects in compliance with site SOPs, Company Guidelines/ Procedures as well as agencies regulation supporting business goals;
- Responsible for compendia updates (USP, EP, BP, CP, etc.) of analytical methods, including compendial acceptance criteria of analytical techniques, sampling, reporting, and statistical analysis of analytical results;
- Participates in site audits, regulatory and corporate inspections including support to audit responses as required as an SME (Subject Matter Expert).
- Guides the QC/QA personnel on quality issues and ensure implementation of quality related improvements, procedures and guidelines;
- Participation in cross-functional/global teams.
- Participates in lab investigations and responsible for impact assessment, RCA.
- Responsible for actively contribution to realization of corporate policy on safety, health and environment;
- Demonstrates personal commitment with respect to working safely, healthy and environmentally friendly.
- Bachelor's degree (HLO) preferably in Biotechnology, Chemistry, or relevant field;
- At least five years of relevant experience in Quality Control or Quality Assurance in pharmaceutical industry;
- Experience with documentation system and preferably with SAP;
- Knowledge and experience with quality and compliance guidelines, cGMPs;
- Knowledge of industry guidance and respective regulations of Analytical Methods Validation, Equipment Qualification, Quality Control or Quality Assurance, Quality (Management) Systems, Documentation, QC Deviations/ CAPA and Change Controls;
- Technical knowledge in testing techniques;
- Experience with Technical Writing, Root Cause Analysis, Failure Mode & Effect Analysis (FMEA), CAPA establishment and Lean Six Sigma;
- Effective project management planning skills and ability to communicate on prioritization and bring others on the same page;
- Computer literacy knowledge;
- Ability to work under minimum supervision, team work oriented and a hands- on mentality;
- Strong focus on clients and end-user;
- Good communication skills, pro-active and flexible;
- Excellent interpersonal and communication skills (oral and written) in Dutch and English. We have more Quality positions available in Boxmeer, or other pharma companies in the south Brabant / Belgium.
Contact for more info: Elke van den Boom
e.vandenboom @ progressive-nl.com or 020 530 5888
Sthree Holland is acting as an Employment Business in relation to this vacancy.