QA Regulatory Compliance Specialist

Reporting to the Quality and Compliance Director, you will be the primary contact for the MHRA for all licencing submissions and regulatory issues relating to Custom Pharmaceuticals Ltd's own products. As Subject Matter Expert in the regulatory process, you will be responsible for maintaining the regulatory database and ensure MAH and internal personnel strictly adhere to agreed systems and SOPs. You will also deputise for our Senior QA Compliance and CD Officer in relation to Home Office interactions.

What you will be doing;

• Coordinating and maintaining aspects of the Quality Management System as assigned.


• Manage licensing activities for CPLs own products ensuring compliance with appropriate legislation


• Maintenance and communication of electronic regulatory file information for each product.


• Supporting application and renewal of MHRA (GMP licences) & Home Office (CD) licences.


• Supporting MHRA, Home Office and Customer audits as required.


• Managing change controls from MAHs with a regulatory impact to ensure QP's only certify products in compliance with the latest available licence information.


• Performing internal audits.


• Coordinating and maintaining aspects of the Quality Management System as assigned, which may include:

+ Change control
+ Technical agreements
+ Product Quality Reviews
+ Batch manufacturing and packaging records review and update
+ Regulatory files compliance checks


• Pharmacovigilance (PV) Responsibilities:

+ To be company point of contact for QPPV
+ To fulfil role of 'Technical Administrator' where referenced in QMS documentation
+ To ensure all medical enquiries, product complaints and adverse drug reactions concerning Custom Healthcare's products are recorded on the appropriate form and referred promptly to the relevant persons, as appropriate
+ To maintain the medical enquiry spreadsheet
+ To assist with the review and issue of Pharmacovigilance SOPs
+ Provide and maintain records of Pharmacovigilance training for Level 1 and Level 2 personnel. Conduct spot checks on training files and provide monthly updates to QPPV on PV training status
+ To assist the QPPV with all pharmacovigilance activities as applicable
+ To ensure all pharmacovigilance files are stored at Custom Healthcare Ltd (paper and electronic) including ICSR files, SOPs and the pharmacovigilance system master file
+ Co-ordinate the submission of safety variations and provide regulatory update to QPPV


• Degree level qualifications in an Engineering / Science based discipline or equivalent, or Educated to GCSE/A-Level or equivalent experience


• Previous experience within the pharmaceutical industry some of which should be in a Regulatory compliance role


• A good understanding of Good Manufacturing Practice, pharmaceutical legislation and sources of reference


• Knowledge of requirements for statutory QA compliance objects (TA, PQR etc.)


• An understanding of EU regulations for the pharmaceutical industry


• A familiarity with QA and QC procedures


• Good communication, planning and organisational skills


• Attention to detail and accuracy when checking data and documentation for compliance


• Good computer skills (Competent in Microsoft Word and Excel)


• Strong documentation skills and systems compliance experience is necessary


• Good problem solving skills and ability to persuades colleagues to apply the directives and standards


• The ability to develop and maintain effective working relationships with colleagues and other company personnel


We are looking for candidates who are;

• Highly organised and able to work under minimum supervision.


• Self-motivated, proactive, and a team-player.


• Able to prioritise workload.
  
  Custom Pharma Services is located in Brighton, UK since 1979 and is a full-service contract development and manufacturing organisation (CDMO) providing services tailored to your needs, no matter how niche or complex. Custom covers the full spectrum of activities from development through commercial manufacturing for both clinical and commercial use. Specialising in Oral Solid Dosage forms with the ability to handle highly potent drugs and poorly bioavailable compounds Custom really is your one stop resource. With direct access to highly skilled experts offering a partnership approach Custom Pharma Services truly has a molecule first mentality, managing all projects with the end in mind. Custom Can!


Custom Pharma Services is an Investors in People Silver accredited workplace where teamwork and support is encouraged, and where every individual is valued and supported to achieve their full potential because if you can, then Custom Can!

Our benefits package includes:

• Rising holiday allowance to 26 days holiday plus UK bank holidays


• Group personal pension scheme


• Annual profit related company and individual bonus payment based on successful performance


• Life assurance at twice annual salary


• Health Plan with Simply Health including access to a GP or Counselling Services 24/7, money back on prescriptions, optical, dental and physiotherapy


• Ride to work scheme


• Subsidised Gym Membership


• Discount Shopping Portal


• Enhanced Maternity / Paternity Pay


• Employee Referral Scheme bonus of £1,000


• Values based awards


• Free hot drinks vending


Applicants must have the right to work in the UK without requiring sponsorship, we do not hold a sponsorship licence.

Successful candidates will be required to complete a basic disclosure check.