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 **** to serve the renal care market in Ireland, Pinewood evolved over the years under indigenous Irish ownership until its sale in **** 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
Originating, Approving and Issuing Production Documentation (Manufacturing & Packaging)
Originating, Approving and Issuing Standard Operating Procedures (SOP's), in compliance with cGMP requirements
Reviewing SOP's, as per review schedule
Issuing Stability Documentation, approval of testing protocols, review of stability reports
Reviewing Validation protocols & validation reports (including process validation, cleaning validation and equipment validation protocols and reports)
Reviewing Product Development Documents
cGMP training
Internal and external auditing
Investigating and review of deviations and out of specification results
Investigating customer complaints
Proofing and approval of artwork
Maintaining ISO standards
Liaise with customers for products which are contract manufactured
Review Batch Documentation
Any other projects relating to quality standards/requirements as assigned by Quality Assurance Manager/Quality Compliance Manager.
Internal comment investigation
Change control, vendor certification and approval of suppliers, raw material review
Temperature monitoring
CAPA reports
APR's
FPS approval
Support elemental impurities, excipient risk assessments, PQR reporting and production support.
Key Requirements
Educated Degree level - Chemistry, Pharmacy or Biological Science.
with experience within the pharmaceutical industry, preferably within QC or QA or appropriate experience.
Excellent 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.
Comfortable working in a busy, fast paced regulated manufacturing environment.
Comfortable working in a professional, team based environment.
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