Associate Specialist – Quality Control Compliance - Netherlands
- Quality Operations (around 100 people) at our company Biotechnology Operations has the following five sub-functions:
- Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents Hub.
- The Quality Department must ensure adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of products according to corporate policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring.
- Reporting into the Laboratory Supervisor CoE the Associate Specialist – Quality Control Compliance will be responsible for the management of QC deviations and CAPA’s, QC GMP changes, Excel spreadsheets and validation.
- He/ she will be responsible for compendia changes implementation and for providing GMP support to the QC organization by coordinating GMP compliance related projects.
- Performs QC investigations, impact assessment (product, process, validation, etc.), Root Cause Analysis (RCA), investigation protocols and reports related to deviations;
- Responsible for management of QC changes (such as analytical procedures) 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 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 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.
Desired skills & experience
- Bachelor’s degree (HLO) preferably in Biotechnology, Chemistry, or relevant field;
- At least five years of relevant experience in Quality Control 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, 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.
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
A good place to work
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.