Qualified Person

An Exceptional Opportunity for a Qualified Person, to Join a Well Established and Highly Successful Supplier of Speciality Products.

Reporting to the Head of Operations, the QP will be Responsible for Ensuring All Batch Records are Certified in a Timely Manner, Ensuring Product is Released and Available for Delivery to Customers.

The QP will be the Contact Point for the MHRA and Responsible for Administration of the Relevant Marketing Authorisations held by the Company.

Focused on Quality and Regulatory Compliance, the QP will Work Collaboratively with the Quality Team to Effectively Manage All Aspects of Quality of the Company’s Products, Ensuring Compliance with the Business’s Regulatory Requirements.

ROLE

• Certify that Batches of Products have been Manufactured in Accordance with the Basic Principles of Good Manufacturing Practice (GMP) and in Accordance with the Relevant Marketing Authorisation and Released for Sale
• Interact with Colleagues to Ensure the Quality System is Operating Effectively
• On Site(s) Availability to Colleagues for Advice, Guidance and Discussion
• Ensure Proper Implementation, Operation, and Effectiveness of the Quality Management System in Conjunction with the Quality Team
• Completion of Regular Audits for Compliance with Basic Principles and Practice of GMP
• Manage All Regulatory Inspections of the Company’s Sites and Involvement in Any Communications with the Inspectorate
• Maintain Up-to-Date Knowledge and Experience of All Current and Applicable Regulatory Guidance, Relevant to the company’s Products and the Role of a QP
• Supervise and Co-Ordinate Work as Agreed in Technical Agreements between the Company and the Contract the QP Team
• Involvement in Audit and Qualification of Suppliers of Quality Critical Items
• Participate in Assessment and Review of Customer Complaints, Non-Conforming Products, and Deviations

REQUIRED (Essential)

• Degree in Biology, Chemistry, or Pharmacy, or Equivalent
• Member of the Relevant Professional Body
• Eligible to be Nominated as a Qualified Person, According to 2001/j83/EC on a UK Manufacturing Authorisation
• Thorough Understanding of Pharmaceutical Law, Quality Management Systems and the Professional Duties of a Qualified Person
• Experience in Batch Release Activities
• Experience of Regulatory Submissions in both NeeS Format and eCTD Format
• Good Understanding of the Medical Device Directive and Experience in Producing Medical Device Technical Files
• Able to Accommodate Flexible Working Hours, Including Some Travel and Overnight Stays
• Full and Clean UK Driving Licence

REQUIRED (Preferable)

• Manufacture and Batch Release of Medical Devices and Medical Gases
• Compliance Systems for Medical Device Manufacture

REMUNERATION

• £70K, Subject to Qualifications and Experience + Bonus Scheme + Company Car/Allowance + Pension Scheme, (Employee 5% Employer 3%) + Flexible Discounts Scheme eg Retail Vouchers + Death in Service Insurance (x4 Annual Salary)

RESPOND

• Call Luke Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail luke@arxconsultancy.com with Your Application, Including Your Current CV