jobs in Dungarvan, County Waterford

Pinewood Healthcare is a leading developer, manufacturer and marketer of healthcare products, currently employing over 320 people across two sites in Tipperary and Dublin. Originally established in 1976 to serve the renal care market in Ireland, Pinewood evolved over the years under indigenous Irish ownership until its sale in 2006 to the Wockhardt Group, an Indian global pharmaceutical and biotechnology company headquartered in Mumbai, India. Wockhardt employs over 7,000 people across 27 nationalities with a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland (Pinewood Healthcare).

The Analytical Services Facilitator is a significant people manager role within the Analytical Services department of Pinewood Healthcare. Reporting to the Analytical Services Manager, the role holder will provide a supporting role to the Analytical Services Manager in all technical aspects and oversight of the individual departments. The role holder will provide technical support to all laboratory operations on site at Pinewood’s Ballymacarbry manufacturing facility, including stability and validation, quality control (raw materials and finished products).

The Analytical Services Facilitator directs, establishes, and plans the overall policies and goals for Pinewood’s laboratory operations. Working closely with the supervisors and other functional managers in the Quality department, the role holder will also work in close collaboration with Operations, Production, Planning, Procurement, Regulatory, Supply Chain and Export Sales to ensure that effective cross-functional business processes are maintained, supporting the supply of existing and new products.

Key Responsibilities include but not limited to:

• 
  Instrumental in developing a culture of quality and critical review across Pinewood Laboratories (Stability & Validation, QC) in compliance with Good Laboratory Practice (GLP). Good Manufacturing Practice (GMP).
• Responsibility for the dissemination of information relating to quality to the wider business.
• Overall support and management of all laboratory staff, ensuring they are properly trained, with proper guidance provided where necessary, including preparation of budgets.
• Responsible for co-ordination of training, development, and competency assessment of team members across Pinewood laboratories
• Ensure that all Pinewood laboratories operate in accordance with the regulatory guidelines of the Health Products Regulatory Authority (HPRA).
• Ensure change is managed appropriately and reported, trended, and reviewed.
• Ensure that data integrity (ALCOA) principles are embedded in the culture of laboratory operations.
• Manage and review non-conformities including user complaints and internal non-conforming events e.g. Deviations and OOS reports.
• Responsible for the oversight of a document control system for all laboratory SOPs.
• Develop and produce regular reports for laboratory meetings and on an ad-hoc basis when requested.
• Ensure that the laboratories are safe working environments for all laboratory employees.
• Plan, implement procedures and policies to continually improve the capabilities of Pinewood laboratories.
• Generate metrics to track and support laboratory performance.

Key Requirements

• 
  BSc qualified in a technical discipline with 10+ years’ industry experience, including 5+ at manager level.
• Strong, working knowledge of the pharmaceutical industry, including GMP, GDP and GLP.
• Extremely capable in metric generation, data trending and document control processes.
• Strong ambition to drive excellence and continuous improvement across Pinewood laboratories.
• Outstanding organisational and time-management skills.
• Ability to leverage/collaborate effectively with internal and external stakeholders
• Excellent written and verbal communication and interpersonal skills.
• Strong problem-solver.
• Resourceful.
• Independent, critical thinker with strong decision-making skills.
• Comfortable working in a busy, fast paced regulated manufacturing environment.
• Solid team management skills and experience/ability in working well with others.