Technical Services Laboratory Analyst

Pinewood Healthcare is a leading developer, manufacturer and marketer of a range of generic, ethical and over-the-counter (OTC) healthcare products. The Company employs over 320 people across two sites in Tipperary and Dublin. Pinewood holds a licence from the Health Products Regulatory Authority (HPRA) to manufacture a range of pharmaceutical products including oral liquids, suspensions, creams and ointments.

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 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. Wockhardt has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland (Pinewood Healthcare).

The Technical Services Laboratory Analyst will be based at Pinewood's manufacturing site in Ballymacarbry, Co. Tipperary. In this role the analyst will perform routine analysis related to process/cleaning/method validation, to support investigations by conducting analysis, perform routine TOC analysis and analysis for new/alternative raw material assessments.

The work will support projects related to GMP compliance, efficiency improvement and cost saving requirements within the company. The analyst will work closely and collaboratively with other members of the Technical Services team, as well as business development/commercial value streams to achieve goals.

Key Responsibilities

• Ensure that all work carried out is in compliance with the required standards conforming to company cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
• Be aware of existing quality procedures.
• Comply with GLP/GMP and safety requirements at all times.
• Daily calibration of laboratory equipment and completion of associated paperwork.
• Receipt and log‑in of process validation samples for testing.
• Perform analytical testing in accordance with associated regulatory and procedural requirements and ensure that laboratory documentation is kept up to date at all times.
• Carry out swabbing/sampling and analysis relating to cleaning validation through approved protocols.
• Carry out testing on process validation samples through approved protocols.
• Carry out testing to support investigations and to assess alternative/new raw material introduction.
• Carry out testing for method validation through approved protocols.
• Complete laboratory reports in a timely manner.
• Perform data and document review to support reports or investigations.
• Perform troubleshooting and fully investigate out of specification results.
• Carry out laboratory activities to complete change control and CAPA actions.
• Maintain laboratory in a clean and well‑organised status at all times.
• Any other duties as deemed appropriate and as designated by the role holder's line manager.

Skills, Qualifications and Experience Requirements

• BSc in Chemistry or other appropriate discipline.
• Minimum 1 year's experience in a pharmaceutical R&D / testing environment is preferred.
• Experience in validation activities beneficial but not a requirement.
• Excellent analytical skills.
• Knowledge of HPLC is a prerequisite.
• Excellent technical writing skills.
• A thorough understanding of current cGMP, Health and Safety and COSHH regulations.
• Compliance to ALCOA and all policies, procedures, ethical standards and processes.
• Demonstrated ability to operate both independently and in team settings.

Personal Attributes

• Outstanding organizational and time‑management skills.
• Strong 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.
• Resourceful, quick learner, problem solver, critical thinker, attentive to detail.

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