Responsible Chemist / Qualified Person - Biotech
Do you want to have a role in which you will be responsible for the release of bulk drug product and drug substance in full compliance with quality procedures, legal guidelines, quality guidelines and market authorization? Do you want to give advice on improvements of quality related issues, in order to ensure an optimal quality of released products and processes?
You will be part of Quality Operations
Quality Operations (around 125 people) at MSD Biotechnology Operations Oss must ensure adequate quality systems and controls are in place to support the manufacture, testing, storage, and distribution of biotech drug substances according to corporate policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring. The department is built up of 3 main groups, i.e. Q IPT (supporting operational processes/ batch release), Quality Control (testing of incoming materials, intermediates, drug substance release & stability) and Compliance (support the business with effective Quality systems and ensuring adherence to those systems).
Quality IPT has the responsibility to support the end-to-end processes of the production departments (IPTs), i.e. raw materials dispositions, batch records review, drug substance disposition, approval of changes, minor deviations and deviations associated to releases.
For more information about MSD Biotech, please watch the MSD Biotech Oss video below.
Reporting into the Associate Director IPT Quality - DSP (Downstream Processing) you will be responsible for the contribution to the functional areas strategy by initiating, prioritizing and monitoring quality improvements.You will work within general standards of industry, governmental expectations and policies and guidelines. You will ensure execution of releases, in line with quality procedures, guidelines and in line with FDA and EU-GMP directives, and compliant with market authorization. You will release drug substance, bulk product manufactured by IPT’s and analytical results. You will review and approve documents, deviations and changes that may impact product quality and you will co-ordinate the execution of the recall procedure.
Warehouse/IPT/QC activities in Compliance
• Ensure monitoring and auditing of the functional areas activities concerning compliance and take necessary action, in line with quality procedures and guidelines;
• Ensure that processes are in compliance with relevant regulations;
Guidance • Guide the functional areas on quality issues and ensure implementation of quality related improvements, procedures and guidelines;
• Ensure the correct decision-making and involve the functional areas to ensure and retain the required level of expertise and quality;
• Sponsor and drive continuous improvement within the functional areas and Quality operations.
• In co-operation with functional areas and in line with quality procedures and guidelines, accountable for the handling of (major) deviations and the handling of customer complaints, including implementation of CAPA’s.
Administration and documentation
• Monitor, initiate and ensure administration and implementation of data (e.g. performance indicators) and documentation (e.g. SOP’s);
• Understanding of and insight in the historic and current status of data and documentation.
Supplier and Agreement Management • Active contribution to suppliers management and agreements (in particular, but not limited to, Quality Agreements);
• Support in all areas related to Suppliers and Agreements. Work closely with other organizational department within MSD and always in line with current and active quality procedures, guidance and legislation and directives.
• Active contribution to realization of corporate policy on safety, health and environment;
• Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.
• Bachelor’s Degree in Science (Chemistry, Pharmacy, Engineering or related science) to enable qualification as a Responsible Chemist;
• Alternatively, Master’s or higher degree in relevant field to be eligible for acceptance as a QP by IGJ;
• At least 7 years of relevant experience in the pharmaceutical industry;
• In-depth knowledge of and experience with quality and compliance guidelines (industry guidance and respective regulations) of multiple areas like Production, Validation, Qualification, Quality Assurance, Quality Control, Quality (Management) Systems, Regulatory Affairs, Quality Agreements, Documentation, Inspection and Auditing;
• Technical knowledge in manufacturing/ packaging processes and testing techniques;
• Technical Writing, Root Cause Analysis, Failure Mode & Effect Analysis (FMEA), CAPA establishment and Lean Six Sigma;
• Effective planning skills and ability to convert quality mindset into practice and to bring others on that same page;
• Computer literacy knowledge and statistical knowledge;
• Strong focus on clients and end-user;
• Ability to work under minimum supervision and team work oriented;
• Excellent interpersonal and communication skills, oral and written
in Dutch and English.
We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive and the summary below will give you an idea of what you can expect.
• Competitive salary and a 3% year-end bonus;
• 35,5 days of leave;
• Attractive collective health care insurance package with considerable reduction rates;
• Solid Pension Plan;
• MSD Incentive Plan (bonus);
• Travel allowance for commuting;
• Numerous training, coaching and e-learning modules for long term job opportunities and development.
MSD 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.
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.
For more information about the position, please contact Peter Gloudemans, Associate Director IPT Quality - DSP, by phone: 0412 66 13 98 or 06-21527737.
If you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter.