Junior QMS Manager

We are currently searching for a Junior QMS Manager to join our client based in Southwest London! Within this role you will be responsible for managing the companys QMS system and monitor KPIs to ensure a well-controlled and time managed system.

If you are an established Junior QMS Manager, or at QA Specialist level and keen to step up to the next level, this role will offer the chance to work with an amazingly supportive team and an interesting portfolio of products within Womens Health, Bone Health and Endocrinology.

Responsibilities:

• Ensure all GMP / GDP activities are performed in compliance to relevant guidelines
• Timely management of change controls, deviations and CAPAs including their closure and effectiveness review. Process for Quality Risk Management and its documentation
• Ensure review of all company SOPs are in accordance with review periods
• Perform scheduled self-audit of internal SOPs and processes to ensure compliance
• Support the Head of Quality Assurance in the QA Continuous Improvement Plan and annual QA objectives
• All relevant staff must be trained in GDP and demonstrate compliance, additional awareness is required for specific staff in GMP, the Falsified Medicines procedure and stringent handling of specific product categories.
• Conduct Technical Quality Agreement reviews to ensure timely updates and review TQA tracker regularly
• Review and maintain PQR tracker
• Produce and present monthly QMS review report and maintain record of trends
• Generate and monitor QMS KPI
• Co-operate with marketing authorisation holders (MAH), QPs and national competent authorities in the event of recalls
• Compliance of company processes and systems to GMP / GDP guidelines at all times
• Line management of one team member

Required Experience:

Good understanding and of GMP / GDP including:

• EU and UK regulations with regard to the Wholesale Distribution activity.
• Knowledge of the role of the Home Office in relation to the handling of Controlled Drugs.
• Knowledge of the Falsified Medicines Directive 201162EU.
• Knowledge of the role of the European Medicines Agency (EMA) and use of EUDRAGMDP.
• Knowledge of EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines.

• Relevant knowledge and experience related to the distribution of medicinal products
• Be a member of a professional body with a published code of conduct
• Good inter-personal and communication skills to communicate complex information to others and be able to put across ideas in a clear and concise manner and present a well-structured case
• Ability to work under pressure and to tight time deadlines with prioritisation of work
• Degree level in a Life Science subject or equivalent in relevant experience