Job Details: Head of Quality


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
Head of Quality


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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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

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