Diposting di: Lain-lain di Durham | Terkirim: |
The Role
The chosen candidate will be based at either the client's Newcastle or Luton sites, with the requirement of commuting to the other site (either Newcastle or Luton) for a minimum of one day per week.
Our Quality Assurance department is key to making sure the products we make and distribute are of the highest standard and that all our departments are working in compliance with Good Manufacturing Practices. We are looking to add a Responsible Person to the team.
As a Responsible Person, your responsibilities will include, though will not be limited to:
Ensuring that a quality management system is implemented and maintained.
Managing authorised activities and the accuracy and quality of records.
Ensuring that initial and continuous GDP training programmes are implemented and maintained.
Coordinating and promptly performing any recall operations for medicinal products.
Ensuring that relevant customer complaints are dealt with effectively.
Ensuring that supplied and customers are approved.
Approving any subcontracted activities which may impact GDP.
Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
Deciding on the final disposition of returned, rejected, recalled, or falsified products.
Having full knowledge of the Licence Holder and the activities that it undertakes.
Ensuring that the Licence Holder is complying with the conditions of the licence issued.
Ensuring that the guidance on Good Distribution Practice (GDP) is complied with.
Ensuring that products are being stored under the correct storage conditions.
Regularly monitoring all named sites.
Receiving reports when tasks are delegated to the Deputy Responsible Person.
Being vigilant, to ensure that falsified medicinal products do not enter the supply chain.
Keeping appropriate records of any delegated duties.
Approving any returns to saleable stock.
Ensuring that any additional requirements imposed on certain products by national law are adhered to.
* Understanding relevant legislation and its application including:
* Human Medicines Regulations 2012 (SI 2012/1916)
* Directive 2001/83/EC as amended
* Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products of Human Use (2013/C 343/01)
Having a working knowledge of the role and scope of the MHRA and EMA including:
* The inspective process
* Licensing
* Maintenance of the WDA(H)
* Assisting with product quality complaints when RP input is required.
* Undertaking project work as agreed with the Quality Director.
* Actively promoting GXP Advising and assisting any member of QPL staff when requested with GDP-related issues.
* Maintaining a general awareness of matters relating to Pharmacy and reporting to any member of senior management, those which may be directly relevant to the company.
* Signing on as Responsible Pharmacist for the Registered Pharmacy when required.
* Performing Quality Approval of MoD over-labelling orders and approving new or amended specifications.
* Partaking in the internal and external audit programs on behalf of the organisation.
* Supporting the Validation and Health and Safety departments.
As with all Group employees, you'll also be asked to:
* Ensure the work you do is of a high standard and that Group procedures and policies are followed.
* Act as an ambassador for the business, presenting the Group in a positive way with clients, customers, and colleagues.
* Work flexibly and efficiently to meet customer needs, whilst maintaining the highest possible professional standards.
* Always maintain confidentiality and security.
To be successful in this role, you should be able to demonstrate:
* Previous experience as a responsible person
* Strong, up-to-date knowledge of Good Manufacturing Practices
* A supportive nature - and good team-playing mentality
* Being capable of working towards KPIs
* Excellent communication skills
* The ability to work at pace and in a high-pressured environment
Working hours for this role are 09.00 - 18.00, Monday - Friday