Qualified Person in Ashford, Kent

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc. UMEDICA's manufacturing facility, located in Vapi (Gujarat), is approved by global regulatory. UMEDICA was founded in 1983 and has business operations in more than 85 countries including the USA, Canada, EU, UK, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries. We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.

Job Purpose

To act as the named Qualified Person responsible for the certification and release of medicinal products in compliance with UK regulations, ensuring patient safety, product quality, and continuity of supply. The role also provides leadership in creating and improving a Quality Management System (QMS), ensuring regulatory compliance, and enabling efficient and timely batch disposition through effective cross-functional collaboration.

Key Responsibilities

• QP Certification & Compliance
  • Perform duties of a Qualified Person in accordance with UK legislation, including the Human Medicines Regulations 2012, and guidelines from MHRA.
  • Certify and release batches for sale, ensuring compliance with Marketing Authorisations (MAs), GMP/GDP requirements, and applicable legal and regulatory frameworks.
  • Ensure compliance with EU GMP Annex 16 and the Orange Guide.
  • Perform risk-based assessment of batch certification, including clinical risk where required.
  • Provide QP declarations to support importation activities.
• Batch Review & Quality Oversight
  • Review batch documentation, deviations, OOS/OOT results, and investigations to enable timely batch release.
  • Provide guidance on documentation gaps, CAPAs, and effectiveness checks to ensure timely closure and continuous improvement.
  • Ensure efficient batch disposition without compromising compliance or patient safety.
• Quality Management System (QMS)
  • Lead the development, maintenance, and continuous improvement of the QMS in line with evolving regulatory requirements.
  • Ensure ongoing compliance of the Manufacturer’s/Importer’s Authorisation (MIA) and associated licences.
  • Drive a culture of quality, compliance, and continuous improvement using Lean principles.
• Regulatory & Inspection Readiness
  • Act as primary contact for regulatory authorities and support inspections and audits.
  • Ensure inspection readiness through internal audits and continuous compliance monitoring.
  • Support preparation and maintenance of product licences, including variations and renewals.
• Cross-functional Collaboration
  • Work closely with Quality, Regulatory, R&D, Supply Chain, Commercial, and Pharmacovigilance teams to ensure seamless operations.
  • Build effective working relationships with global and site leadership teams to enable efficient decision-making and product release.
  • Maintain regular communication with Head Office and key stakeholders.
• Continuous Improvement & Governance
  • Apply Lean principles to optimise processes, reduce inefficiencies, and maintain compliance.
  • Monitor and report QP-related performance metrics to senior leadership.
  • Participate in quality review meetings and governance forums.
• Training & Development
  • Provide GMP and QP-related training to internal stakeholders.
  • Maintain Continuous Professional Development (CPD) to remain eligible as a QP.

Key Accountabilities

• Ensure that Marketing Authorisation (Assembly Only) requirements have been met for all batches of medicinal products, prior to certifying and ‘release for sale’ of these batches to the market.
• Ensure that principles and guidelines of cGMP (Directive 2003/94/EC) as interpreted in the EU Guide to cGMP and cGDP (The Orange Guide), have been followed.
• Manage the development of the Quality Management System covering all activities with the Group in line with the evolving regulatory requirements and changes and ensuring appropriate reporting to Management.
• Ensure effective maintenance of granted licenses including variations and renewals.
• Oversee all aspects of trademark notifications including preparation of samples and maintaining up to date knowledge of legal requirements, including assessing the applicability of the “Specific Mechanism” to potential products.
• Undertake regular internal inspections on an ad-hoc basis across the site to ensure standards are being maintained. Suggest improvements/non-compliance and propose corrective actions on consultation.
• Co-ordinate with appropriate Regulatory Bodies and ensure inspection requirements are fully satisfied.
• Maintaining inspection readiness.

Qualifications & Experience

• Eligible to act as a Qualified Person under UK legislation.
• Named or eligible to be named on a Manufacturer’s/Importer’s Authorisation (MIA).
• Degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related discipline.
• Significant experience in GMP-regulated pharmaceutical environments.
• Strong working knowledge of UK/EU GMP, GDP, and regulatory requirements.

Key Skills & Competencies

• Strong decision-making with high accountability.
• Risk-based thinking and clinical judgement.
• Attention to detail and compliance focus.
• Ability to work cross-functionally and influence stakeholders.
• Strong communication and leadership skills.

Additional Requirements

• Willingness to travel to manufacturing sites as required.
• Ability to work in a hybrid and globally connected environment.
• Familiarity with digital/paperless systems (e.g., cloud).