Senior Auditor/ QA Specialist

MAIN PURPOSE:

The Senior Auditor/QA Specialist will be suitably experienced in some, or all of the key focus areas for this role. Role activities will be assigned across the team to suit the experience and skill level of each team member. The Senior Auditor/QA Specialist may be required to cross-train or up-skill in different areas of responsibility as required by business need.

KEY RESPONSIBILITIES:

Service Delivery

To manage and deliver MPI services, such as Auditing, management of MPI’s Quality Management System, the virtual QA service, provide technical advice and support for delivery of client projects and MPI projects.

Project Management

• To provide project management support for clients to establish their requirements and align with the technical, training or auditing services provided by MPI (or additional services as identified).
• To develop client Project Agreements, based on client needs, terms and timelines.
• To project manage assigned MPI projects to ensure project delivery within agreed timelines and budgets.

Business Development / Sales & Marketing

• To keep abreast of changing regulatory standards, industry best practice and emerging trends to provide input to business development and product development opportunities.
• Under the direction of the Business Development/Marketing team, participate in business development and marketing initiatives and programmes.

Communication

• Contribute technical articles to the Company publications as required or requested.

Budgeting

• To input, as requested, into the annual MPI budgeting process.
• To input into the development of MPI and client project budgets as required and to manage the delivery of all assigned projects within the agreed budget.

Customer Service

• To deal with internal/external customer contacts and resolve queries and problems in an appropriate, effective and timely manner.
• To liaise with Clients, regulatory authorities and other external parties as required/requested on behalf of clients and/ or on behalf of McGee Pharma International.

Compliance

• To develop and maintain the MPI quality system.
• To ensure compliance with all MPI company policies and procedures.

Qualifications / Experience

• 3rd Level Qualification in a Science subject, qualification in Quality Management.
• Ideally 10+ years’ experience in the Pharmaceutical Industry in a GMP environment.
• Extensive experience in Auditing (international).
• Ideally experience in Good Distribution Practice or Market Authorisation Holder Compliance.
• High-level computer literacy and competency – Microsoft Office.

Knowledge, Skills & Behaviours

Knowledge

• In-depth understanding of regulatory requirements applicable to the Pharmaceutical Industry, and knowledge of the sources of regulatory information (medical devices and cosmetics industries also considered).
• In-depth understanding of the purpose, objectives and scope of Quality Systems

Demonstrated ability in

• Effectively resolving compliance issues
• Working with third parties
• Creation of third party contracts/project agreements
• Working in cross-functional teams
• Contributing to company programmes or projects
• Managing change, influencing stakeholders and delivering results

Skills

• Strong Communication Skills – strong business English capability
• Strong technical writing skills
• Project Management Skills
• Strong Interpersonal Skills – when working with MPI staff, Associates, clients and external 3rd parties

Dimensions

Commercial Awareness - Understands the vision and strategy of the Company and takes action to support the collective objectives of the business.  Networks appropriately and effectively inside and outside of the Company to build relationships in the interests of the business.

Change - Resilient; flexible. Identifying improvement opportunities and embracing change, helping to overcome barriers and obstacles.

Planning & Organising – Analytical; methodical. Establishing a course of action for self to accomplish a specific goal; good organisation and time management/project management skills.  Ability to differentiate and prioritise activities in line with business priorities.

Teamwork- Supportive of colleagues and customers (internal & external) in a manner that respects each individual and contributes to effective team outcomes.

Drive for Results – Achievement-oriented; decisive and action-oriented.  Setting high standards of performance for self; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.

Customer Focus – Conscientious; communicative; socially confident. Making efforts to listen to and to understand the customer (both internal and external); anticipating customer needs; giving high priority to customer satisfaction.  Excellent interpersonal skills build and establish rapport with customers, clients and other service providers of MPI.

Information Monitoring and Review – Analytical; creative; methodical. Sets up appropriate and effective monitoring and tracking systems to collect and review relevant data to ensure effective control.

Problem Solving – Conceptual; creative; analytical. Securing relevant information and identifying key issues and relationships from a base of information: relating and comparing data from different sources as appropriate in order to reach a decision or make recommendations.

• Excellent remuneration package, bonuses, pension contribution.
• Friendly working environment and challenging projects alongside a talented team.
• Open and collaborative organizational culture with an emphasis on knowledge-sharing.
• Opportunity to participate in a wide range of personal and professional training initiatives.
• Business interaction with a dynamic international team in a global company.
• International work experience and paid business trips.

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