Quality Assurance Officer

About Pinewood Healthcare

Pinewood Healthcare is a major developer, producer, and marketer of healthcare products. The company has more than 300 employees across two sites in Tipperary and Dublin. It began in 1976 serving the renal care market in Ireland and later evolved under Irish ownership before being acquired in 2006 by the Wockhardt Group, an Indian pharmaceutical and biotechnology company based in Mumbai. Wockhardt has more than 7,000 employees representing 27 nationalities and operates across the USA, UK, Ireland, Switzerland, France, Mexico, Russia, and other countries, with manufacturing and research facilities in India, the USA and the UK, plus the Irish manufacturing site at Pinewood Healthcare.

Role Summary

The Quality Assurance Officer will support a regulated manufacturing environment by managing documentation, quality systems, investigations, audits, and compliance activities across production and product quality processes.

Key Responsibilities

• Create, approve, and release production documentation for manufacturing and packaging activities.
• Prepare, approve, and issue standard operating procedures in line with cGMP expectations.
• Carry out SOP reviews according to the scheduled review cycle.
• Issue stability documents, approve testing protocols, and review stability reports.
• Review validation protocols and validation reports covering process, cleaning, and equipment validation.
• Assess product development documentation.
• Deliver cGMP training support.
• Take part in internal and external audits.
• Investigate deviations and out-of-specification results.
• Handle investigations related to customer complaints.
• Review and approve artwork proofs.
• Maintain ISO compliance standards.
• Liaise with customers for contract-manufactured products.
• Review batch records and related documentation.
• Support any other quality-related projects assigned by the Quality Assurance Manager.
• Carry out internal comment investigations.
• Manage change control activities, vendor certification, supplier approval, and raw material reviews.
• Oversee temperature monitoring records and checks.
• Prepare CAPA reports.
• Support APRs, FPS approval, elemental impurity assessments, excipient risk assessments, PQR reporting, and production support.

Personal Attributes

• Strong organisational ability and effective time management.
• Capability to work well with both internal teams and external stakeholders.
• Clear written and verbal communication skills, along with strong interpersonal ability.
• Good problem-solving judgement.
• Resourceful and self-directed approach to work.
• Ability to work independently when required.
• Strong critical thinking skills.
• Comfortable in a busy, fast-moving regulated manufacturing setting.
• Able to contribute in a professional, team-oriented environment.

Education and Experience

A degree in Chemistry, Pharmacy, or Biological Science is required, along with pharmaceutical industry experience, ideally in QC or QA, or another relevant equivalent background.