Quality Training Manager Pharma
|Job Title:||Quality Training Manager Pharma|
|Contact Name:||Laurentina Kennedy|
|Job Published:||over 3 years ago|
The Training Manager will operate in the quality function and will hold responsibility for the management of GMP quality training, education and development in addition to co-ordinating the Training activities for the facility in conjunction with the BU/BSU leads.
The role encompasses:
Training personnel to instil the site quality/GMP values Training and rules as they relate to operations;
Education: Focus on employee understanding of GMP regulations pertaining to their part in producing a consistently high quality process and product;
Development: Continuous evaluation of quality system signals, regulatory and industry changes in order to ensure employee training is enhanced and is focused on aligning the quality system training program with that of industry leaders & Co-ordination of the On-going training programme.
The Training Manager will govern all quality training activities for the site supporting the training needs for all aspects of commercial, clinical and development activities at the site.
The Training Manager will manage the quality training activities as follows:
Quality Training development: Ensure training modules are reflective of changes in industry and regulatory standards. Identify training needs and continuously evaluate training material ensuring training delivery is impactful
Management of training needs in response to quality system signals. Partner with team members in the Continuous Improvement Team to identify adverse trends in the quality system and address appropriate training needs to mitigate risk.
Site GMP Training: Routine GMP training, New Employee Induction
Regulatory Standards Changes: Assessment of Site Training Programs & Employee Education to ensure understanding of impact of regulatory changes
Implementation and management of Compliance Wire (learning management system)
Provide guidance to direct reports to ensure activities are completed as per defined timelines and in a GMP compliant manner.
Manage and motivate team members through effective communication and effectively assign responsibility and resources to achieve required goals.
Hold performance meetings according to company policy.
Maintain capacity as per business needs including recruitment & management of staff.
Coach and develop team members to support the Company?s succession planning.
Maintain strong relationships with management and colleagues in the business units and the quality function, direct reports and customers. Articulate the necessary quality requirements in a clear, concise and persuasive manner.
Management of Compliance Wire (Learning Management System) implementation
Management of site quality training activities to drive the importance of quality compliance and adherence to the company quality training standards at the site.
Development of Learning plans for business and function units
Management and Co-ordination of all site training activities. Continuously looking at novel ways to deliver training across the site.
Co-ordination of the area resources to deliver a quality and efficient support service.
Proactively validate training programs and functional trainers
Provide quality input as required, providing direction on day to day activities relating to Training
Foster an environment of continuous improvements for the Training Program by identifying and implementing efficiencies and quality improvements.
Provide direction to personnel directly/indirectly reporting ensuring activities are undertaken in a compliant and efficient manner.
Co-ordinate QMS Management for area of responsibility.
CORAL: Review and approval of assigned documentation & component drawings as deemed necessary.
Support site MOH and customer inspections as deemed necessary
Co-ordinate site Training meetings as deemed necessary
Represent the Training group at internal/external meetings as required
Attend all routine meetings as required or arrange an appropriate deputy. For example:
Departmental/ANDON Board/APEX/Site Project meetings/H&S Meetings
BU Leads; Trainers; Quality Coach, Senior QA Manager & Quality Management teams; including the Director of quality operations & Corporate QA
Interactions with all functions including operations, logistics, engineering, facilities, HR
Education and Experience/Knowledge:
Proven track record in a quality discipline in the Pharma/Medical Device environment.
Third level Science qualification: Minimum at BSc degree level
Training experience in a GMP regulated manufacturing environment
Experience in a wide variety of Learning and Development training delivery methods
Experience in successfully developing, delivering and improving high-quality learning programs
For further information on this Quality Training Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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