Contract for two days per week
Our client is a well-established healthcare business that currently manufactures a number of brand name products worldwide.
The QP is responsible for ensuring that each batch of medicinal products has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP).
Key skills and responsibilities
- Perform the legal duties of a Qualified Person (QP) as specified under EC directive 2001/83/EC as amended for the certification and release of medicinal products.
- To ensure compliance with the requirements of Annex 16 of the EU GMP guidelines.
- Maintain and develop the systems and procedures within the company’s Quality System to ensure compliance with Marketing Authorisations, regulatory requirements and current GxP requirements.
- Conduct periodic internal audits and ensure appropriate CAPA is raised when required.
- Conduct audits of third party suppliers and service providers as required.
- Co-ordinate and help manage significant quality incidents e.g. deviations, customer complaints, product recalls and implement CAPA as necessary.
- Author/approver of GMP documentation as required.
- Attend Management Review Meetings and approve meeting minutes as required, and to be involved in subsequent CAPA and improvement activities.
- Apply effective leadership in support of the Head of Quality in order to help achieve departmental and business objectives.
- Participate in inspections by Regulatory Authorities and customers.
- To assist with the development and implementation of GxP training programs.
- Act as a QA representative on project teams ensuring appropriate levels of GxP are implemented.
- To be available to Production staff to assist in resolving day-to-day issues.
- To maintain knowledge of current guidelines and GMP’s as part of continual professional development.
- To complete the QP log book when batches are certified.
- To coach staff as required and explain decisions to ensure education of the Quality team is contemporaneous.
- Current knowledge and experience in UK & EU pharmaceutical legislation (21 CFR 211 would be advantageous).
- Enthusiastic approach to compliance by helping and educating colleagues.
- Experience in coaching and mentoring staff through decisions and risk assessments.
- Able to find pragmatic solutions to regulatory challenges.
- Excellent written and oral communication skills, and high attention to detail.
- Ability to work under pressure and maintain strict deadlines.
- Proven problem solving skills and analytical mindset.
- External & internal auditing experience.
- Experience in working in manufacturing environments.
- Experience of participating in Regulatory Authority audits (MHRA & FDA).
- Able to prioritise and deal efficiently with variable workload.
Qualified Person/QP/Manager/batch release/EC Directive/Good Manufacturing Practice/GMP
Harris Lord is acting as a recruitment agency for this role
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