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).
Key areas of responsibility (include but not limited to): Undergo on-going training for laboratory requirements, GLP/GMP requirements and Health and Safety/Manual Handling as required.
Carry out development and validation analysis as directed by Laboratory Supervisors/Managers.
Prepare such reagents and standards as are needed to carry out the above testing.
Label these materials and document the preparation as required.
Provide test data and results to Laboratory Supervisor.
Report any Deviations or Out of Specification/Out of Expectation results observed.
Maintain the laboratory premises and equipment in a clean and safe manner.
Report any problems/defects immediately they are noticed.
Remove reagents from the lab as they reach their expiry date.
When fully trained in a test method or the use of a Laboratory instrument, assist in the training of other analysts in the use of these methods/instruments.
When fully trained in a test method, the analyst may review others analysts work and assist in the training of less experienced analysts.
Other duties as required.
Key Requirements: Bachelor degree in Chemistry or other appropriate discipline and a minimum of 1 years' experience in GMP pharmaceutical manufacturing; Experience of HPLC/GC analysis would be an advantage A thorough understanding of current cGMP, Health and Safety and COSHH regulations; Sound interpersonal skills Experience in cleaning/process/method validation testing beneficial but not a requirement Compliance to ALCOA and all policies, procedures, ethical standards and processes; Excellent technical writing skills. Outstanding organisational and time-management skills.
Exceptional team player with the ability to leverage/collaborate effectively with internal and external stakeholders.
Excellent written and verbal communication and interpersonal skills.
Comfortable working in a busy, fast paced regulated manufacturing environment.