KEY RESPONSIBILITIES:

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

• the batch and its manufacture comply with the provisions of the marketing authorisation (including the requirements for importation where relevant);
• 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);
• the principal manufacturing and testing processes have been validated (account has been taken of the production conditions by review of the relevant documentation);
• 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.
• all the necessary checks and tests have been performed.
• 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.

• Overall Management of the supplier management programme within Chanelle Pharma.
• Review & Approval of New Vendors into the site
• Act as main point of contact for Vendor
• Report Non-conformances from Vendors in a timely manner
• Monitoring of all ASLs/ AMLs and ensuring compliance to same.
• Monitoring of supplier API Technical Agreements, Excipient and primary packing and printed packing materials.
• Establish and maintain records of supplier’s performance
• Vendor evaluation – evaluation of potential new suppliers/materials. Final overall assessment prior to approval, liaison with all relevant departments as a part of implementing change.
• Ensuring supply chain routes including manufacturer, brokers, agents, transport companies that maybe involved. Collation of relevant compliance documentation from same. Obtaining supply chain route validation where necessary.
• Ensuring storage and transport conditions for all materials and ensuring compliance. 
• Management of Supplier risk assessment for excipients and Packing materials.
• Ensure all work carried out is in compliance with the required standards and all direct reports are trained to conform to Company policies and procedures.
• Preparation and Maintaining Audit schedules
• Maintaining Audit reports and follow up on CAPA plan from vendors.
• Providing support to QPs in preparation of QP declarations.
• Implement suggestions for improvement / development of the Quality System
• Create and Present monthly and quarterly metrics.
• Any other duties as assigned by the Head of Quality/ Senior QA Manager

COMPETENCIES:

• Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands are key communication skills.
• Ability to build relationships and collaborate with others is vital.
• Strategic decision-making within the business as an influencer.
• A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
• Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPIs to monitor the performance
• Positive and proactive person who is energized by having great responsibility.
• Practical, action-orientated approach to managing priorities and teams.
• Strong computer skills in MS Office

QUALIFICATIONS:

• A Bachelor’s degree in a Science related discipline.

• Desirable a minimum of 5+ years’ experience of working in a similar role in the Pharmaceutical Industry.

• Knowledge of EU quality-related pharmaceutical regulations.

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

• VDU

WORK ENVIRONMENT: (eg. Office, Production)

• Office