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Contact Info
Libby O'Donoghue
Life Science

+353 1 507 9254
[email protected]
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Details

QA Manager (Part time)


Reference:LOD A008456 Location: Cork
Qualification:DegreeExperience:7-9 Years
Job Type:Part-TimeSalary: Not Disclosed
May be suitable for: QA Manager

JOB PURPOSE:
The Quality Manager is responsible for delivery of quality assurance activities at this Biotechnology facility for the full product lifecycle to ensure products are manufactured in accordance with cGMP, EudraLex Sterile Manufacturing Annex 1 and all other applicable Regulatory requirements.


The Quality Manager will execute the site QA activities at the site in order to protect the safety, and quality of products, ensuring we meet our Global Customers stringent requirements and specification while assuring the security of the company's business and global markets.


This position requires a strong leader who will partner closely with our Senior Leadership team.
As with all site personnel, the Quality Manager is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department.

This is a permanent part time position.

RESPONSIBILITIES:
The responsibilities of the Quality Manager include the following:

  • Lead the site Quality Risk Management (QRM) program, provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
  • Lead the site Validation Programme through the approval and management of protocols as required i.e. facilities, process, method validation.
  • Lead the site Contamination Control Strategy (CCS).
  • Lead the quality team in the management of the Quality Management systems ensuring all systems are compliant including but not limited to Non-Conformance/ CAPA Management Change control Activities, Supplier Management Programme, Documentation Management and Customer Complaint Processes.
  • Lead in the preparation and hosting of external audits, e.g., Customer Audits, Certification Audits etc.
  • Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
GENERAL RESPONSIBILITIES:
  • Participate fully in any cross functional training initiatives.
  • Drive and promote the corporate values within the workplace.
  • Motivation, training, discipline and appraisal of Quality Assurance/Control staff.
  • Actively foster, in cooperation with other staff, an ethos and culture of safety awareness.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the Managing Director.
EDUCATIONAL REQUIREMENTS:
  • Primary Degree in Scientific discipline
RELEVANT EXPERIENCE:
  • Minimum of 7 years’ experience in the pharmaceutical industry in a Quality role.
  • Minimum of 3 years' experience in a people management role.
SKILLS / COMPETENCIES:
  • Excellent knowledge of Good Manufacturing Practice and the requirements of EudraLex Volume 4 -Annex 1 Manufacture of Sterile Medicinal Products.
  • Must have strong process validation knowledge to include upstream and/or downstream processing.
  • Demonstrable experience managing, motivating and leading a team.
  • A high level of initiative is required.
  • Excellent verbal and written communication skills are essential.
  • Strong project management and organisational skills.
  • Ability to adapt to changing priorities.
  • Experience of single use assembly manufacture is desirable but not essential.