Quality Document Administrator

OVERALL ROLE OBJECTIVE: To work as part of a Quality Document administration team responsible for compilation, issuance and review of GMP documentation. The post holder will assist in the maintenance of the Almac Pharma Services Quality system and will participate in investigations and trending of quality performance indicators as appropriate

JOB SPECIFIC RESPONSIBILITIES: The post holder will: 1. Generate GMP documentation (Master Manufacturing and Packaging Specifications, SOP’s, specifications, validation documentation etc) in the approved formats. 2. Issue batch records in accordance with the Production schedule as outlined in Almac Pharma Services internal procedures. 3. Issue and retrieve GMP documentation to / from departments as assigned. 4. Circulate quality system related documentation (change requests, deviations, CAPA, suspect analytical results, complaints etc.) to all relevant departments. 5. Manage and distribute controlled documents, maintaining current effective versions in hard copy and electronically. 6. Ensure that all designated Document Control storage/ archive areas are tidy, presentable, and organised in a logical way. 7. Archive retrieve and track GMP associated documentation. 8. Collate and review data for QA reports and investigations. 9. Maintain all quality system indexes and electronic tracking systems e.g. WOLF.

This role requires coverage beyond normal working hours on a regular basis and it is a condition of your employment that you are able to fulfil this requirement of the role. GENERAL ROLE RESPONSIBILITIES: Quality Ensure GMP is adhered to in all areas of work.

Almac Pharma Services’ Quality Mission; To operate within a quality excellence framework that is both efficient and effective and continually assures safe and efficacious product to the patient.

The post holder will, support the quality mission of the business by: - Ensuring exceptional and reliable quality in all aspects of work and recognising that quality determines the extent of success. - Engaging with the Pharmaceutical Quality System to ensure that quality records are completed accurately and proactively managed in line with committed timelines. Quality performance against set targets is a key goal and aligns with business objectives. - Actively contributing to the Quality Vision outlined by the Senior Management Team of reducing the gap between “where we are today” versus “where we want to be today”.

Health & Safety Understand Company’s Health & Safety Policy and follow all company HSE procedures. Report all accidents or any unsafe conditions in the workplace.

Training and Development Ensure training has been received before undertaking specific duties and that all training is recorded in training records.

Human Resource Management Adhere to all HR policies and procedures, to include all absence policies and procedures. Communication Communicate within your own department to ensure that all relevant information is forwarded to the appropriate personnel on a regular and timely basis. Provide regular updates to your line manager regarding progress on required duties and the status of any projects.

Equal Opportunities Observe and adhere to the company's Equal Opportunities and Dignity at Work policies ensuring that a neutral and harmonious work environment is maintained in which bullying and/or harassment does not occur.

Core Competency Framework Ensure that all job specific responsibilities relating to the overall role objective are carried out in accordance with the requirements outlined within the Almac core competency framework. QUALIFICATIONS

3 x A-Level (or equivalent) at Grade C or above EXPERIENCE

Previous experience within a quality system or manufacturing environment KEY SKILLS

Proven ability to work effectively on own initiative as well as effectively contributing to the team environment Effective communication skills (both written and verbal) Proficiency in use of IT applications (Word, Excel, Outlook etc) Excellent attention to detail Proven ability to plan and prioritise workload