Senior QAO - Onward Supply Chain

Job Details: Senior QAO - Onward Supply Chain

Vacancy Name:Senior QAO - Onward Supply Chain

Contract:Permanent

Location:Romford, Spilsby Road

Daily Work Times:Monday to Friday 8:30am - 5:00pm

Basic Hours Per Week:37.50

Job Title:Senior Quality Assurance Officer - Onward Supply Chain

Department:Quality Systems and Compliance

Reports to:Quality Systems Team Lead

Location:Romford

Job Level:Level 4

Job Purpose:
The QAO for Onward Supply Chain is required to lead activities related to the onward supply chain for Romford products, working closely with the International Team, Warehouse Team, Supply Chain, and the UK Headquarters Team (Responsible Person) to ensure activities are performed in compliance with GDP requirements and the Quality Management System.

Main Responsibilities & Duties:

Onward Supply Chain for Romford Products:

• Leads quality activities related to the onward supply chain for Romford Products.
• Acts as a point of escalation for all onward supply chain issues.
• Acts as the quality point of contact for Distributors, Wholesalers, and Customers, where Ethypharm Romford acts as a CMO, and supports resulting activities.
• Ensures appropriate documentation and record-keeping for activities undertaken relating to Romford products.
• Ensures that any suppliers and customers are approved prior to use.
• Liaises with suppliers to arrange for the approval of Quality Technical Agreements / Distribution Agreements.
• Supports change management with respect to supply chain impact assessments.
• Supports Product Quality Complaints related to onward distribution activities.
• Supports the validation of supply chain routes in conjunction with the Quality validation Team.
• Supports recall activities if required.
• Provides input to and supports the design and delivery of training programs relating to onward supply chain activities.
• Develops, maintains, and reports on KPIs relating to quality supply chain performance for Romford and identifies improvement opportunities.
• Attends the UK Headquarters Distribution Quality meetings as the Romford representative.
• Supports activities relating to review and closure of notification types (i.e. CAPA, Product Quality Complaints, Deviations) related to area of responsibility, ensuring actions completed to required timescales.

Additional Responsibilities:

• Applies the principles of continuous improvement by identifying and actioning improvements and efficiencies for areas of responsibility.
• Provides quality support for internal audits, customer audits, and Regulatory inspections and supports the resolution of deficiencies in a timely manner to completion.

Data Integrity:

• Applies the principles of Data Integrity in all the work that they conduct.

General:

• Exhibits the WoW behaviours of Challenging, Collaboration, and Continuous Improvement in all activities.
• Ensures Compliance to all SOPs applicable to the role and maintains SOP training matrix.
• Complies with all Health and Safety Policies and Procedures.

Person Specification:

Requirements:

Essential:

• Educated to degree level (in appropriate science-related subject) or equivalent is preferred.
• Minimum 3 years’ experience working in a Quality Systems environment, within the pharmaceutical industry.
• Strong knowledge of pharmaceutical supply chain processes.
• Experience in GDP activities.

Desirable:

• Previous experience of regulatory authority inspections.
• ERP system experience (SAP).

Qualifications:

• Educated to degree level (in appropriate science-related subject).
• Lean sigma trained.
• Lead auditor trained.

Knowledge:

• Comprehensive understanding of EU regulatory guidelines related to distribution activities (Green guide).
• Demonstrated knowledge of the Pharmaceutical Quality System.
• Good understanding of Risk Management.

Skills & Personal Qualities:

Skills:

• Ability to determine risk and communicate level of risk and risk acceptance to others.
• Excellent verbal, written, and numerical skills able to convey complex subjects accurately, precisely, and concisely.
• Ability to communicate at all levels of the organisation and tailor style appropriately to ensure stakeholder engagement.
• Good attention to detail with an analytical approach to work.
• Active listening.
• Highly organised and able to work under pressure and to tight deadlines.
• Can persuade and negotiate with others using facts and data to convince others but has the ability to listen and change their own opinion.

Personal Qualities:

• Completer finisher.
• Good eye for detail.
• Team player.
• Persuasive and able to influence to achieve required goals and objectives.
• Self-motivated.
• Able to manage own workload.
• Ability to work in a diverse cultural environment and create a spirit of inclusivity.
• Has a desire to drive performance through a continuous improvement culture.

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