ID: 47864
Quality Release Officer (BSc)
Geen aanbiedingen geplaatst
Omschrijving
Functieomschrijving
Reporting into the Quality Assurance Lead, the Quality Release Officer ensures that the activities are in compliance with cGMP, regulatory and legal requirements and products released to the market are in line with regulatory filings. Ensures compliance with quality procedures, guidelines, market authorizations and relevant regulations.The Quality Release Officer delivers approved production records, completed deviations and changes and supports the release of raw materials/contact materials/intermediates and drug substances. Furthermore, the Quality Release Officer approves qualifications and validations, registration documents, authorized specifications and stability-quality guarantee, completed complaints, approved Technical Quality Agreements and evaluation of Suppliers.Job ResponsibilitiesNext to this, the Quality Release Officer will be accountable for: In line with quality procedures and guidelines monitor and audit IPT activities (e.g. daily presence and walk-through audits) concerning compliance and take necessary action; Ensure the validated status of GMP processes, systems and computer systems, in line with quality procedures and guidelines. In line with quality procedures and guidelines check and approve CJAs and SOP´s; Perform risk assessments on deviations and changes related to quality and GMP. Start-up additional investigation and support root cause investigation when applicable. Approve Correct of actions or Preventive actions in consultation with Responsible Chemist; In co-operation with functional areas support and check incidents investigations andcustomer complaints handling; In line with quality procedures and guidelines compile data for annual reviews, analyze data and administrate results; Supportive role during internal/external audits; Advise the departments within scope and ensure implementation of quality related knowledge, procedures and guidelines. Support continuous improvement, in line with quality procedures and guidelines.
Functie-eisen
Bachelor Degree or similar level by working experience; At least 3 years of relevant experience (warehouse experience in pharmaceutical or food industry); Knowledge of GDP, GMP, quality and compliance guidelines; Proactive; Strong focus on clients and quality/compliance; Being able to bring others on the same page with regard to quality mindset; Passion of for innovation, Lean and Continuous improvement; Ability to influence and communicate with all levels of the organization from shop floor to senior management; Teamplayer.
Sollicitatieprocedure
Balans offers you a challenging and responsible job for the longer term. You have the opportunity to develop yourself and to work in dynamic and international teams.Do you have any questions regarding this vacancy? Please do not hestitate to contact Noëmy van de Loo on 088-8900835.Are you an experienced laboratory professional and looking for the next step in your career? Balans Laboratorium mediates in a professional and thorough manner for senior scientists and managers with a laboratory or food background. If you are open to further broaden and deepen your career at a new employer, we suggest you visit our website to see how we can assist you in your search. If you want to leave us your details so we can contact you when we have an interesting position available for you, you can register via our website. Once you have registered, we will contact you within five working days to discuss your specific needs and wishes.
Reporting into the Quality Assurance Lead, the Quality Release Officer ensures that the activities are in compliance with cGMP, regulatory and legal requirements and products released to the market are in line with regulatory filings. Ensures compliance with quality procedures, guidelines, market authorizations and relevant regulations.The Quality Release Officer delivers approved production records, completed deviations and changes and supports the release of raw materials/contact materials/intermediates and drug substances. Furthermore, the Quality Release Officer approves qualifications and validations, registration documents, authorized specifications and stability-quality guarantee, completed complaints, approved Technical Quality Agreements and evaluation of Suppliers.Job ResponsibilitiesNext to this, the Quality Release Officer will be accountable for: In line with quality procedures and guidelines monitor and audit IPT activities (e.g. daily presence and walk-through audits) concerning compliance and take necessary action; Ensure the validated status of GMP processes, systems and computer systems, in line with quality procedures and guidelines. In line with quality procedures and guidelines check and approve CJAs and SOP´s; Perform risk assessments on deviations and changes related to quality and GMP. Start-up additional investigation and support root cause investigation when applicable. Approve Correct of actions or Preventive actions in consultation with Responsible Chemist; In co-operation with functional areas support and check incidents investigations andcustomer complaints handling; In line with quality procedures and guidelines compile data for annual reviews, analyze data and administrate results; Supportive role during internal/external audits; Advise the departments within scope and ensure implementation of quality related knowledge, procedures and guidelines. Support continuous improvement, in line with quality procedures and guidelines.
Functie-eisen
Bachelor Degree or similar level by working experience; At least 3 years of relevant experience (warehouse experience in pharmaceutical or food industry); Knowledge of GDP, GMP, quality and compliance guidelines; Proactive; Strong focus on clients and quality/compliance; Being able to bring others on the same page with regard to quality mindset; Passion of for innovation, Lean and Continuous improvement; Ability to influence and communicate with all levels of the organization from shop floor to senior management; Teamplayer.
Sollicitatieprocedure
Balans offers you a challenging and responsible job for the longer term. You have the opportunity to develop yourself and to work in dynamic and international teams.Do you have any questions regarding this vacancy? Please do not hestitate to contact Noëmy van de Loo on 088-8900835.Are you an experienced laboratory professional and looking for the next step in your career? Balans Laboratorium mediates in a professional and thorough manner for senior scientists and managers with a laboratory or food background. If you are open to further broaden and deepen your career at a new employer, we suggest you visit our website to see how we can assist you in your search. If you want to leave us your details so we can contact you when we have an interesting position available for you, you can register via our website. Once you have registered, we will contact you within five working days to discuss your specific needs and wishes.