Our Current vacancies:

RP – Responsible Person

We are currently looking for a MHRA registered Responsible Person (RP) with for Good Distribution Practices to join a leading company based in Hampshire. This is an exciting opportunity for a RP who wants to further develop their career.

 Role Requirements: 

As the RP,  you will be tasked with, but not limited to ensuring that the responsibilities for the following are defined and  processes are in place to ensure compliance of the licence holder with the Human Medicine Regulations, GDP and their Quality Management system:  

• communicating and co-ordinating with the MHRA and leading inspections and audits
• ensuring the quality management system is implemented and maintained and adequately manages risk within the supply chain and matches the client’s business models and covers vendor management. To include the completion and storage of records
• approval of suppliers, customer and vendors whose activity may impact GMP/GDP
• management of change and risk to identify, analyse and take necessary preventative measures pro-actively and re-actively manage change and risk within the business
• ensuring that initial and continuous training programs are implemented and maintained
• co-ordinating and promptly perform any recall operations for medicinal products
• ensuring that all relevant customer complaints are dealt with effectively
• ensuring that suppliers and customers are approved
• ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
• keeping appropriate records of any delegated duties
• taking decision on the final disposition of returned, rejected, recalled or falsified products and approve any returns to saleable stock. Responsible for ensuring any additional requirements imposed on certain products by national law are adhered to
• ensuring all import and export activities are compliant with relevant regulations.
• host external audit activities and manage any CAPAs when require
• analysis of internal metrics and trend reviews of key quality processes and escalate when required
• review and approve batch documentation or QP certification when required
• prepare data for product quality reviews
• review and approve validation protocols and validation reports when required
• lead specific projects when required

Requirements for the Role: 

• 3 years experience as a Responsible Person
• Import and Export experience
• Excellent administrative skills and ability to create effective procedures and quality management systems

• Microsoft Office and be able to draft and critically review reports

Quality Assurance Team Member

We are currently looking for a Quality Assurance Analyst to join a leading company based in Hampshire. This is an exciting opportunity for a Quality Assurance Team Member who wants to further develop their career.

Role Requirements:

• To complete regular audit checks on external communication with clients providing feedback to the applicable RP
• Complete monthly checks on client documentation providing feedback to the applicable RP.
• To take responsibility for resolving client complaints and ensuring adequate responses to those complaints within identified timeframes
• Liaise with other areas as required to gather the facts of each complaint
• Make decisions on the validity of each complaint and recommended corrective action
• Issue decisions to clients and seek feedback on our complaint handling process
• To manage all Quality records and documentation
• Aid in the review and implementation of the PCL quality system.
• Aid the RP in completion of Quality documentation for our clients.
• Aid the RP with external audits
• Provide RP support on their responsiblities
• Ensure that only current issues of documents are available at point of use (both hard copy and electronic copy)

Administrator

We are currently looking for an Administrtor to join a leading company based in Hampshire. This is an exciting opportunity for a Administrator who wants to further develop their career.

Role Requirements:

• Providing a high level of administration to support the team.
• Working closely with the quality team with the administration and filing of client files.
• Working with the Training Coordinator to book delegates on the training.
• Communicating with the team and clients over the phone and email
• Creating documents
• Formatting documents
• Preparing minutes
• Research
• Diary Management
• Answering the phones

Please contact us for more details at [email protected] or call 01252 375362.