Technical Services Laboratory Analyst

About Pinewood Healthcare

Pinewood Healthcare is a prominent developer, manufacturer, and marketer of a broad range of generic, ethical, and over-the-counter healthcare products. The company operates over two sites in Tipperary and Dublin, employing more than 320 staff. Pinewood is licensed by the Health Products Regulatory Authority (HPRA) to produce various pharmaceutical items, including oral liquids, suspensions, creams, and ointments.

Founded in 1976 to serve Ireland's renal care market, Pinewood evolved under Irish ownership until its acquisition in 2006 by the Wockhardt Group, a global pharmaceutical corporation based in Mumbai, India. Wockhardt is a multinational organization with over 7,000 employees across 27 countries and manufacturing and research facilities worldwide, including Ireland.

Role Overview

The Technical Services Laboratory Analyst role is based at Pinewood's manufacturing site in Ballymacarbry, Co. Tipperary. The analyst will conduct routine analyses related to process, cleaning, and method validations to aid investigations, perform total organic carbon (TOC) analyses, and analyze new or alternative raw material assessments. These tasks support GMP compliance, efficiency enhancements, and cost-saving initiatives within the business.

The role requires close collaboration with other members of the Technical Services team and business development or commercial units to meet objectives.

Key Responsibilities

• Ensure all laboratory work complies with company cGxP standards, SOPs, regulatory guidelines, and safety and environmental policies.
• Maintain awareness of existing quality procedures and adhere strictly to GLP/GMP and safety protocols.
• Perform daily calibration of laboratory equipment and accurately complete related documentation.
• Receive and log process validation samples for testing purposes.
• Conduct analytical testing aligned with regulatory and procedural requirements while keeping laboratory records up to date.
• Perform swabbing, sampling, and analysis for cleaning validation following approved protocols.
• Test process validation samples as per protocols.
• Support investigations and new/alternative raw material evaluations by performing relevant analyses.
• Execute method validation testing within established protocols.
• Complete laboratory reports promptly and support report or investigation activities through data and document review.
• Troubleshoot and thoroughly investigate any out-of-specification results.
• Implement laboratory activities related to change control and CAPA actions.
• Maintain the laboratory environment in a clean, organized manner.
• Undertake additional tasks as delegated by the line manager.

Qualifications and Experience

• Bachelor of Science degree in Chemistry or a related field.
• At least one year of experience in pharmaceutical R&D or testing environments preferred.
• Experience with validation activities is advantageous but not mandatory.
• Strong analytical skills and proficiency with HPLC techniques are essential.
• Excellent skills in technical writing.
• In-depth knowledge of current cGMP, Health and Safety, and COSHH regulations.
• Adherence to ALCOA principles and all relevant policies, procedures, and ethical standards.
• Ability to work both independently and collaboratively within teams.

Personal Traits

• Exceptional organizational and time-management abilities.
• Team-oriented mindset with effective collaboration skills with internal and external stakeholders.
• Strong verbal and written communication as well as interpersonal skills.
• Comfortable working in a fast-paced, regulated manufacturing environment.
• Resourcefulness, quick learning aptitude, critical thinking, problem-solving capabilities, and keen attention to detail.