Our client based here in Co Galway are looking for Manufacturing Supervisor – Components.
This is a permeant role on day shift.
Responsibilities:
- Supervise shift personnel in the manufacture of plant products consistent with high quality and safety standards within the compounding area.
- Ensure compliance with cGMP, FDA, HPRA and other regulations as necessary.
- Review manufacturing documentation post batching ensuring paperwork is complete.
- Promote and support site initiatives including safety programs, lean initiatives, training programs, and consistently interpret & apply all policies, practices and procedures among the compounding team
- Coach and develop team by setting clear objectives, evaluate performance, provide feedback and development plan.
- Ensure quality of product leaving site is at highest standard through compliance to SOPS and general sound decision making.
- Perform investigations in cross functional teams utilizing DMAIC(Define, Measure, Analyze, Improve and Control) methods of problem solving.
- Metrics and outputs to be achieved per the monthly/yearly objectives – IRS/CAPAS closed on time
- Generate picklists for manufacturing (raw materials, excipients, filling components) on Oracle system
- Raise change controls in track wise.
- Introduce and assist validation department in qualification of new equipment to manufacturing.
- Perform other duties as assigned.
Requirements:
- Minimum of a Bachelor's degree (or equivalent) and 3+years of experience. However, a combination of experience and/or education will be taken into consideration.
- Must have supervisory and people management experience
- Knowledge of manufacturing processes within a pharmaceutical/ medical device environment (previous experience within compounding would be a distinct advantage) is an advantage.
- Desirable understanding of cGMP regulations as well as gowning experience for a Grade C environment or equivalent
- Must have effective problem solving and interpersonal skills
- Excellent communication skills and have the ability to consider all the facts and make sound decisions
- Ability to establish and maintain good working relationships with all levels in the organization.
- Excellent written and verbal communication skills with all levels of employees.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706 717