Are you a senior Quality Professional with experience in developing and implementing Quality Management Systems in a start up environment? Do you have experience with the FDA & MHLW? Would you like to work in Poland for a multinational company with significant operations across Europe and Russia? If you have this level of experience, please send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat
Head of Quality - Biotech - Poland
Employer
Our client is one of the leading innovators in the Biotech field in Poland, with a new state of the art R&D facility and ambitious growth plans over the next 5 years.
Job Description
Develop, implement and supervise the operation of the Quality Management System in accordance with the Client's requirements and Quality Polices.
Ensure that all products and processes in the division have built-in quality and meet all internal and external requirements.
Coordinate activities related to the preparation of the Unit for pharmaceutical inspection and audits (HHAA and partners).
Conduct activities related to the QMS in product development, manufacturing, testing, storage, and distribution.
If necessary, develop new policies and quality procedures, prepare necessary documentation including the creation of a comprehensive Quality System specifically designed for the company.
Ensure proper course of action during qualification and validation, through the participation and coordination of qualifying activities.
Interact with regulatory authorities
Have Quality Authority over the defined operations and represent the company in related quality matters with Regulatory Authorities, Customers, and users.
Requirements:
Degree in biologics, chemistry, pharmacy, biotechnology or related, supported by min. 5 years of work experience in the pharmaceutical industry, including 2 years operational experience in the evaluation of pharmaceutical products in the area of control or quality assurance. Specifically: acting as Qualified Person under EU concept or similar.
Knowledge and experience of technologies for producing sterile pharmaceutical products
Understanding analytical technologies related to the evaluation of pharmaceutical products, specifically in Biological products
Excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, specifically in the ICH guidance environment (US, Japan EU) with emphasis in development and production of sterile and biologic drug products and drug substances (API ́s)
Understanding the issues and needs of validation and continual improvement systems in pharmaceutical manufacturing
Knowledge and experience of quality management systems, with specific understanding in managing deviations, investigations, change control and corrective/preventing actions
Very good knowledge of English both, written and spoken
Ability to work with MS Office
Ability to make decisions. Experience in Managing groups of people working in the field.
Ability to work as a team member
Package:
€120K per annum basic
Bonus - typically 20%
Polish Tax Rates: 0-20K @ 18%, 20K+ @ 32%
Medical Insurance
Life Insurance
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
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QA/QC Jobs
Are you a senior Quality Professional with experience in developing and implementing Quality Management Systems in a start up environment? Do you have experience with the FDA & MHLW? Would you like to work in Poland for a multinational company with significant operations across Europe and Russia? If you have this level of experience, please send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat
Head of Quality - Biotech - Poland
Employer
Our client is one of the leading innovators in the Biotech field in Poland, with a new state of the art R&D facility and ambitious growth plans over the next 5 years.
Job Description
Develop, implement and supervise the operation of the Quality Management System in accordance with the Client's requirements and Quality Polices.
Ensure that all products and processes in the division have built-in quality and meet all internal and external requirements.
Coordinate activities related to the preparation of the Unit for pharmaceutical inspection and audits (HHAA and partners).
Conduct activities related to the QMS in product development, manufacturing, testing, storage, and distribution.
If necessary, develop new policies and quality procedures, prepare necessary documentation including the creation of a comprehensive Quality System specifically designed for the company.
Ensure proper course of action during qualification and validation, through the participation and coordination of qualifying activities.
Interact with regulatory authorities
Have Quality Authority over the defined operations and represent the company in related quality matters with Regulatory Authorities, Customers, and users.
Requirements:
Degree in biologics, chemistry, pharmacy, biotechnology or related, supported by min. 5 years of work experience in the pharmaceutical industry, including 2 years operational experience in the evaluation of pharmaceutical products in the area of control or quality assurance. Specifically: acting as Qualified Person under EU concept or similar.
Knowledge and experience of technologies for producing sterile pharmaceutical products
Understanding analytical technologies related to the evaluation of pharmaceutical products, specifically in Biological products
Excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, specifically in the ICH guidance environment (US, Japan EU) with emphasis in development and production of sterile and biologic drug products and drug substances (API ́s)
Understanding the issues and needs of validation and continual improvement systems in pharmaceutical manufacturing
Knowledge and experience of quality management systems, with specific understanding in managing deviations, investigations, change control and corrective/preventing actions
Very good knowledge of English both, written and spoken
Ability to work with MS Office
Ability to make decisions. Experience in Managing groups of people working in the field.
Ability to work as a team member
Package:
€120K per annum basic
Bonus - typically 20%
Polish Tax Rates: 0-20K @ 18%, 20K+ @ 32%
Medical Insurance
Life Insurance
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
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QA/QC Jobs
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
