Title:  Sr. Specialist, Quality Assurance & Deputy Responsible Person (UK)

Senior Specialist, Quality Assurance & Deputy Responsible Person (UK)

JOB PURPOSE:

The Senior Specialist, Quality Assurance & Deputy Responsible Person (UK), is responsible for operating and maintaining the Quality and Quality Management System (QMS) of the UK affiliate, preparing, executing and maintaining all relevant quality records. The role ensures that wholesale distribution activities under the Wholesale Dealer’s Authorisation (WDA(H)), and the planned export activities, comply with Good Distribution Practice (GDP), the Human Medicines Regulations 2012 (as amended), MHRA requirements and approved company procedures.

The role administers the document control, deviation, CAPA, change control and complaint systems, coordinates investigations and risk assessments, and provides quality data and trending to support the Responsible Person’s decisions. Quality decisions and approvals remain with the Responsible Person. The role works closely with Commercial, Supply Chain, Customer Service, Regulatory Affairs and Hikma’s global Quality functions.

The postholder, in the RP’s absence, acting as the deputy RP performs RP duties in accordance with the RP procedure, with the authority to approve or reject product release and to quarantine stock, independently of commercial considerations.

KEY ACCOUNTABILITIES

Deputy Responsible Person

• Act as Deputy RP in accordance with the RP procedure and maintain the knowledge and availability required to deputise at any time.

• In the RP’s absence, perform RP duties, including RP releases, final disposition of returned, rejected, recalled and falsified products, and recall coordination, escalating to the RP where required.

• When deputising, approve or reject product release and quarantine stock, independently of commercial considerations.

• Do not approve quality records prepared by the postholder; escalate these to the RP or to the designated alternate reviewer defined in the RP procedure.

Document Control & QMS Maintenance

• Administer document control: issue, version control, distribution, withdrawal and archiving of SOPs, forms and work instructions.

• Maintain the periodic review schedule, prompting document owners ahead of due dates.

• Keep the Quality Manual, organisational chart and responsibility matrix up to date.

• Control the master document index and retention schedule, ensuring records meet data integrity (ALCOA+) principles.

Deviations, Investigations & CAPA

• Log and triage deviations, non-conformances and quality incidents on intake.

• Coordinate investigations and facilitate root cause analysis with process owners, drafting investigation reports for RP review.

• Log CAPAs, assign ownership, track due dates and escalate overdue actions.

• Design and execute CAPA effectiveness checks, and trend deviations and CAPA by category, source and recurrence.

Change Control & Complaints

• Administer the change control system: intake, classification and routing for RP approval.

• Coordinate cross-functional impact and risk assessments using ICH Q9 tools, and track implementation actions through to closure verification.

• Maintain the change log and perform periodic trending.

• Manage complaint intake and acknowledgement, coordinate investigations, trend complaints and draft closures for RP review.

Inspections, Self-Inspections & Regulatory Compliance

• Support the RP in preparing for and hosting MHRA inspections, including preparing documentation and drafting deficiency responses and CAPA plans for RP approval.

• Support the self-inspection programme and audits of subcontracted activities.

• Track inspection, self-inspection and audit commitments through to closure.

• Maintain up-to-date knowledge of GDP, the Human Medicines Regulations 2012 and MHRA guidance, and support the RP in assessing and implementing new or updated requirements.

RP Support & Quality Management Review

• Prepare quality data and KPIs for the Quality Management Review (QMR).

• Support the RP in supplier and customer qualification, including bona fide checks.

• Support returns and recall management, including mock recalls.

• Support initial and continuing GDP training and maintain training records.

Continuous Improvement

• Contribute to the alignment of UK quality systems with global quality standards, working with Corporate Quality and Quality Systems functions.

• Identify and drive improvements to quality system processes, tools and ways of working.

COMMUNICATIONS & WORKING RELATIONSHIPS 

Internal:

• UK Responsible Person

• UK Commercial, Supply Chain, Customer Service and Regulatory Affairs

• The Company Corporate Quality and Quality Systems & 3rd Party Quality CMO (Injectables EU & US)

• The Company manufacturing sites

External:

• MHRA, through the RP and designated company channels

• Customers, suppliers, CMOs and MAH partners

• 3PL, warehouse and transport service providers, auditors and consultants

ESSENTIAL QUALIFICATIONS, EXPERIENCE, & SKILLS

QUALIFICATIONS

Minimum: Degree in Pharmacy, Chemistry, Biology, Biotechnology or another relevant life-science discipline.

Preferred: Pharmacy degree; RP training (e.g., Cogent RP Gold Standard).

EXPERIENCE

Minimum: 5 years of experience in pharmaceutical Quality Assurance within a GDP-regulated environment (wholesale, logistics or distribution), including QMS administration.

Demonstrated experience with deviation, CAPA, change control, complaint and document control systems.

Preferred: Experience as RP or Deputy RP, hosting and/or assisting during MHRA GDP inspections and the export of medicinal products is preferred. Candidates without RP experience must complete RP training.

SKILLS

In-depth knowledge of GDP (EU GDP Guidelines 2013/C 343/01 as applicable in the UK), the Human Medicines Regulations 2012, the MHRA Green Guide and ICH Q9/Q10.

Sound, independent judgement and risk-based decision-making, particularly when deputising for the RP.

Strong organisational skills and attention to detail; ability to meet deadlines in a fast-paced commercial distribution environment.

Clear written and verbal communication, including presenting to management and regulators.

BEHAVIOURAL COMPETENCIES

Planning & Organizing

Taking Initiative & Drive for Results

Collaboration & Teamwork

Communication & Influence

Problem Solving & Decision Making

Change & Innovation

Customer Focus, internal and external

Analytical & Critical Thinking

FUNCTIONAL COMPETENCIES

English proficiency (fluent, written and spoken)

Microsoft Office and eQMS proficiency

Project Management

Quality Assurance & Management

Quality Risk Management

Technical Writing

Policies, Procedures & Work Methods

Good Distribution Practice (GDP)

GDP Inspection Readiness

Data Analysis & KPI Trending

Document Control & Data Integrity