Manufacturing Process Supervisor Purification

Expiring today

Dublin, Dublin West
EUR50000 - EUR60000 per annum + health insurance + 25 days holidays
11 Sep 2019
18 Sep 2019
Manufacturing Supv
Ann Marie Corcoran
Job Type
Manufacturing Process Supervisor Purification

Reporting to the Manufacturing Area Manager, the Manufacturing Process Supervisor is responsible for the start-up, development and execution of the manufacturing specific requirements from a project based environment through to commercial readiness and supervision thereafter. The Supervisor will work across functions to achieve objectives including, but not limited to, Quality, Supply Chain, Manufacturing, Validation, Engineering and H&S ensuring that products meet or exceed all safety, quality, customer service and cost targets.

Key Responsibilities:

Plan, organize, develop and execute the manufacturing department start up and the commercial manufacturing ramp up plan. Support construction, process development/selection, documentation generations, qualification and validation from the initial project phase right through to the commercial manufacturing phase.
Assure the appropriate interaction with support groups such as Quality, Technology, Engineering & Maintenance, Supply Chain, Regulatory Affairs, EHS and Human Relations. Lead shift huddles, planning meetings, etc.
Responsible to ensure that the aseptic products are produced in a timely and safe manner which meet or exceed all specifications, quality standards, HPRA & FDA regulations and other Health Authority guidelines.
Ensures the use of qualified personnel on all validated and calibrated equipment and processes.
Monitor, record, display and drive Key Performance Indicators for the Department, including but not limited to; Overall Equipment Effectiveness (OEE), production yields reports, manpower & facilities utilization reports.
Generate and support quality investigations and contribute to CAPA reporting and take ownership for closure.
Act as a cross functional partner to identify and prioritize continuous improvement opportunities from the initial pre-validation phase right through to commercial manufacture, to improve the quality, safety, reliability, RFT and productivity of the manufacturing and testing processes.
Selects and maintains qualified personnel in all positions, assists in career planning and conducts performance reviews.
Communicates regularly with employees and management about department performance, plans and initiatives.
Develop and maintain a training curriculum for staff ensuring that 'standard work' practices are employed.
Safety and Environmental officer for the area responsible for audit preparation for the area, monitoring and communication of incident and accident trends. Updating of health and safety metrics and communication.
Ensure supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance, monitoring absenteeism and managing holiday requests and balances etc.
Review and complete all Company documentation in line with cGMP requirements
Performs other duties as assigned.

Key Requirements:

Bachelor's degree required: Emphasis on Biology, Chemistry, Manufacturing or Mechanical Engineering or closely related scientific / technical discipline essential.
Candidates must have a minimum of 3 years of related experience leading and managing people in a pharmaceutical, GMP, or EU regulated environment.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Must be proactive, results oriented, and have strong attention to detail.
Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Promote a culture of continuous improvement through the use of Operation Excellence tools and methodology.
Comprehensive knowledge and understanding of cGMPs, EU regulations, and industry guidelines highly desired
Must be available to work shift as directed by the organization.
Excellent verbal and written communication skills in the English language.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

Contact Ann Marie Corcoran for more information.

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