Quality Specialist (supply chain)
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Holland Netherlands.
regarding global supply chain quality. You may also be acting as a licensed Responsible Person.
- Coordinates and supports GMP/GDP Quality Systems, including continuous improvement initiatives;
- Works on matters related to GDP/GMP compliance processes (Regulatory compliance and risk management);
- Interprets law, regulations and the companies Global policies for their relevance for future process improvements;
- Implements and maintains quality standards procedures;
- Interprets audit and inspections trends and prepares action plans based on these findings;
- Risk assessments and implementing risk mitigation projects, policies and systems;
- Integrates current legal and regulatory standards and competent authority expectations;
- Actively participates in and contributes to global business process improvement activities;
Discusses with and provides information to:
o Various (senior) staff members and colleagues f;
o QA/RA and Medical representatives from affiliates in the region;
o Senior Managers and QPs of manufacturing sites;
o May be required to represent the company and interact with senior quality systems and compliance professionals from other companies;
o Leads multifunctional teams and/or projects
o industrial pharmacist or GDP Responsible Person is a plus;
o 2/3 years of experience in the pharmaceutical industry (in a similar position);
o Experience with leading process improvement, compliance and auditing activities;
o Knowledge and experience of Quality Systems (GMP, GDP) is a must
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.
The Company
The Global Supply Chain Quality department is part of the Downstream Supply Operations. They guide and support to develop, maintain and manage quality systems and reduce risks. The Department works closely with the various functional areas to implement business processes, that are in compliance with relevant rules and regulations and support compliance.Role Description
As a Quality Specialist you are responsible for all GMP/GDP related activities for the Supply Operations and for overseeing the legal and regulatory complianceregarding global supply chain quality. You may also be acting as a licensed Responsible Person.
Responsibilities
- Implementing and maintaining the Quality Systems for (Global Supply Chain & GMP/GDP) related activities;- Coordinates and supports GMP/GDP Quality Systems, including continuous improvement initiatives;
- Works on matters related to GDP/GMP compliance processes (Regulatory compliance and risk management);
- Interprets law, regulations and the companies Global policies for their relevance for future process improvements;
- Implements and maintains quality standards procedures;
- Interprets audit and inspections trends and prepares action plans based on these findings;
- Risk assessments and implementing risk mitigation projects, policies and systems;
- Integrates current legal and regulatory standards and competent authority expectations;
- Actively participates in and contributes to global business process improvement activities;
Discusses with and provides information to:
o Various (senior) staff members and colleagues f;
o QA/RA and Medical representatives from affiliates in the region;
o Senior Managers and QPs of manufacturing sites;
o May be required to represent the company and interact with senior quality systems and compliance professionals from other companies;
o Leads multifunctional teams and/or projects
Requirements
o University degree, preferably in biosciences (pharmacy, biotechnology);o industrial pharmacist or GDP Responsible Person is a plus;
o 2/3 years of experience in the pharmaceutical industry (in a similar position);
o Experience with leading process improvement, compliance and auditing activities;
o Knowledge and experience of Quality Systems (GMP, GDP) is a must
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.
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