KEY RESPONSIBILITIES:

· Responsibility for batch release as per EU guidelines by ensuring the following requirements have been met:

o the batch and its manufacture comply with the provisions of the marketing authorisation (including the requirements for importation where relevant);

o manufacture has been carried out in accordance with GMP (in the case of an imported batch that it has been manufactured to standards equivalent to EC GMP);

o the principal manufacturing and testing processes have been validated (account has been taken of the production conditions by review of the relevant documentation);

o any deviations or planned changes have been duly authorised. Any changes requiring variation to the marketing authorisation have been notified and authorised by the relevant authority.

o all the necessary checks and tests have been performed;

o all necessary production and Quality Control documentation has been completed and endorsed by the appropriate staff;

· Forward any incoming reports (whether it is through post, e-mail, fax or in Person) regarding Pharmacovigilance / Adverse Action Reports to the relevant QPPV in a timely manner.

· all audits have been carried out as required by the QA system;

· take into consideration any other relevant factor that may affect the quality of the batch.

· Conduct Routine Quality Audits of the facility to ensure compliance with current EU GMP, be proactive in resolving issues which may arise.

· Set up and maintain the Internal Audit schedule and ensure its completion as per schedule.

· Prepare and conduct annual GMP training programme.

· Conduct External audits, compile External Audit reports and manage associated responses.

· Management and assistance with the site change control system.

· Management of the customer complaints system and associated CAPA’s.

· Provide technical support for New Product Introductions and existing Products, ensuring compliance with the registered dossier

· Review /lead Process investigations and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary.

· Ensure Process transfer is documented and conducted in accordance with Regulatory Standards.

· Quality review and approval of manufacturing documentation for Chanelle & third party contract manufacturing.

· Provision / Updating of existing Quality Manual Procedures in order to ensure compliance with EU GMP

· Contributing to the overall improvement of the company from a Quality / GMP perspective with an emphasis on continuous improvement of the quality system.

· Preparation of Key Performance Indicators for the Quality department and also assisting in the maintenance of records for the company KPIs as per Quality management review requirements.

· Ensure timely feedback on customer/production queries as appropriate.

· Preparing product quality review schedule and reports for Chanelle and third party contract manufacture products.

· Assist in product investigations and ensuring risk assessment approach is applied

· Management of the deviation system and associated CAPA’s.

· Collating monthly trends and assisting the Quality Material Review Board meetings.

QUALIFICATIONS & COMPETENCIES:

· Bachelor’s degree in a science-based discipline with a minimum of 1-2 years’ experience in a pharmaceutical manufacturing environment with working knowledge of EU GMP and US FDA Guidelines

· Displays key behaviours such as:

• Takes direction and asks questions
• Relates well to the rest of the team
• Develops own technical skills
• Takes a methodical, systematic and structured approach to organising work
• Ability to prioritise decision making differentiating between urgent and non-urgent
• Escalates issues appropriately
• Offers to help others when needed and creates a sense of harmony in the team
• Displays flexibility and shows willingness to learn and do that little bit extra

PHYSICAL DEMANDS:
Health & Safety requirements (eg. Manual Handling Training)

• VDU

WORK ENVIRONMENT:

• Office