We are currently looking for a Qualified Person QP to join a Pharmaceutical company based in the South East. As the Qualified Person QP you will be responsible for ensuring inspection ready Quality Systems are implemented, whilst also being tasked with batch release duties in accordance with EU Directive 2001/83/EC
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Qualified Person QP will be varied however the key duties and responsibilities are as follows:
1. To set up and maintain a quality management system in compliance with current GMP requirements and provide clients with support for all aspects of GxP compliance for example auditing, validation, training.
2. You will be advising clients on all aspects of GxP, Manufacturing site audits (both API and finished dose form) and provide training / education as necessary to both in-house staff on aspects associated with GxP and provide support for clients undergoing Regulatory Inspections.
3. To ensure the business obtains and maintains the necessary manufacturing licences to support its business needs, maintain an awareness of current legislation associated with GxP and regularly interact with the various EU Regulatory Agencies.
4. As the Qualified Person / QP you will also be responsible for carrying out Batch Certification where named as a Qualified Person responsible for batch release (as described in EU Directive 2001/83/EC as amended), on a Marketing Authorisation held by the client.
To be successful in your application to this exciting opportunity as the Qualified Person QP we are looking to identify the following on your profile and past history:
1. A relevant life science or higher qualifications with proven experience of working in the pharmaceutical industry or a regulatory authority inspections division.
2. We are looking for broad GxP experience where you may have worked in all facets of the industry ranging from R&D; Production; Quality Control; Regulatory and Quality Assurance.
You must have the experience to work across a range of dose forms (oral, topical, inhaled, injectable); biological experience would be an advantage
3. A working knowledge and practical experience releasing commercial batches is essential. Any exposure to investigational products would be advantageous.
Key Words: Qualified Person | QP | Senior Manager | Quality Manager | Quality Assurance Quality Systems | GXP | GMP | GCP | Audit | Manufacturing | Batch | EU Directive | Dosage Forms
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Posted: 7th December 2017
- Expires: 4th January 2018
- Reference: J4868