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Job Details

Quality Manager

Company: Thornshaw Recruitment
Location:
Reference: TD9662
Closing Date: 19 Mar 18
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

New opportunity for a Quality Manager to join a leading medical devices company.   This role sits with the senior management team, lots of autonomy and great opportunity to join a well-established company.

Requirements:

New opportunity for a Quality Manager to join a leading medical devices company.   This role sits with the senior management team, lots of autonomy and great opportunity to join a well-established company.

POSITION SUMMARY

Responsible for Quality Assurance and managing all resources dedicated to that function.  Coordinate Regulatory Affairs for the relevant Europe, Middle East, Africa and Asia (EMEAA) markets.
1.    ESSENTIAL JOB FUNCTIONS:
1.1.    Maintain the quality system in accordance with EU GMP Volume 4 Part 1 (Drug Products)
1.2.    Maintain the quality system in compliance with Annex V, Annex VII and Article 11 of the Medical Device Directive 93/42/EEC, and relevant EMEAA regulations.
1.3.    Ensure that satisfactory standards of quality, sterility, and biological safety are maintained and ensure the Quality System always meets ISO 13485 and any other standards which may apply from time to time.
1.4.    Act as Quality System Management representative as outlined in ISO 13485 and any other applicable Quality Management Standard.
1.5.    Ensure Class I and Class IIa products meet all the relevant provisions of the Medical Device Directive 93/42/EEC in relation to CE marking.
1.6.    Ensure that all specifications, processes, materials and products are appropriate for their intent and purpose and in compliance with approved, agreed requirements.
1.7.    Ensure all sampling plans and test methods and procedures are appropriate for their intent and purpose.
1.8.    Ensure that Customers requirements are understood and that all responses to Customers are in a timely manner, are accurate and meet / exceed the customer’s needs.
1.9.    Identify and prioritise policies and objectives necessary to achieve and maintain quality standards as committed to in the quality policy.
1.10.    Ensure contributions are actively encouraged from quality department for cost improvement and continuous improvement and ensuring all projects and reports are completed in an accurate and timely manner.
1.11.    Inform the Notified Body of any significant changes in systems or procedures which could potentially affect registration.  
1.12.    Communicate with the relevant Competent Authorities and Notified Body regarding vigilance    activities. Ensure all vigilance activities, including FSCA, are performed in a timely and efficient manner.
1.13.    Ensure all Non-conforming events are investigated, the root cause identified and if necessary escalated to the Corrective and Preventive Action (CAPA) system. Ensure that the CAPA system works effectively.
1.14.    Ensure all resources of personnel and equipment allocated to the quality department are utilized efficiently. 
1.15.    Promote and maintain safety, health and welfare in accordance with regulatory and company policies and procedures. 
1.16.    Lead, motivate and develop the quality team in line with company policy and HR strategy including recruitment, training and performance management.  
1.17.    Communicate effectively and work with teammates and customers from diverse backgrounds and cultures.
1.18.    Prepare and present annual budget for the department and manage activities within the limitations of the approved budget.
1.19.    Support a culture of Continuous Improvement and carry out projects and duties as assigned to you in an efficient, timely and cost-effective manner.
1.20.    Work with the company appointed Qualified Person to ensure all requirements of the site’s Medicinal Product’s Manufacturer’s Authorisation are maintained.
1.21.    To approve or reject, as seen fit, starting materials, packaging materials, and intermediate, bulk and finished products
1.22.    To ensure that the appropriate validations are done.
1.23.    To ensure that the required initial and continuing training of the quality department personnel is carried out and adapted according to need.
1.24.    The monitoring and control of the manufacturing environment.
1.25.    The approval and monitoring of suppliers of materials.
1.26.    The approval and monitoring of contract manufacturers.
1.27.    The monitoring of compliance with the requirements of GMP.
1.28.    Follow Article 51 of Directive 2001/83/EC which details the following:
1.30.1    For medicinal products manufactured within the European Community, a Qualified   Person must ensure that each batch has been produced and tested/checked in accordance with the directives and the marketing authorisation.
1.30.2    For medicinal products manufactured outside the European Community, a Qualified Person must ensure that each imported batch has undergone, in the importing country, the testing specified in paragraph 1 (b) of Article 51.
1.30.3     A Qualified Person must certify in a register or equivalent document, as operations are carried out and before any release, that each production batch satisfies the provisions of Article 51.
1.30.4    The persons responsible for these duties must meet the qualification requirements laid down in Article 49 of the same Directive, they shall be permanently and continuously at the disposal of the holder of the Manufacturing Authorisation to carry out their responsibilities. Their responsibilities may be delegated, but only to another Qualified Person(s).
1.30.5    Follow Eudralex Volume 4 Annex 16 of EU GMP Guide “Certification by a qualified person and Batch Release”.

3.    EDUCATION & EXPERIENCE REQUIRED: 

3.1.    Educated to degree or equivalent level in an Engineering or Scientific Discipline.
3.2.    3/5 years Quality Assurance, or Microbiology in the Medical Device or Pharmaceutical field.
3.3.    Experience with sterilization systems and validation.

4.    KNOWLEDGE SKILLS & ABILITIES: 

4.1.    Be customer focused in an ever-changing dynamic marketplace.
4.2.    Ability to analyse information, draw conclusions and make sound and timely decisions.
4.3.    Ability to deal with ambiguity, rapidly prioritise and respond to change quickly.
4.4.    A passion for continually improving processes with a focus on results.
4.5.    Financially astute and bottom line driven with a good aptitude for numbers.
4.6.    Demonstrated people management skill, a strong team builder with good strategic perspective who possesses strong influencing and communication skills

For further details contact Tina at +353 1 2784671 or email your cv in confidence to tdunne@thornshaw.com.   For a list of all active vacancies log on to www.thornshaw.com

Apply for this job: Quality Manager

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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