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Job Ref.: 1562

Job Title: Senior QA / Quality Manager – Pharmaceuticals – Dublin North – February 2018 - Urgent

Posted Date: 25/02/2018

Sector: Quality

Location: Ireland, Dublin North

Job Type: Permanent full-time

Job description:

Senior QA / Quality Manager – Pharmaceuticals – Dublin North – February 2018 - Urgent

Our client is Ireland's only pharmaceutical consultancy authorised to release investigational and commercial medicinal products into Europe under its own licences and support product importation. Their aim is to become a European Partner to Pharma companies wanting to establish themselves in Europe. They provide contract services to enable pharma companies to import and batch release medicinal products in to Europe in a compliant manner with no significant investment in licence application, maintenance activities or office/personnel costs.

They now wish to recruit an experienced Senior QA / Quality Manager to join their team. The role can be a full time permanent position or be worked on a part time basis. Candidates should have a minimum of 8-10 years’ experience. QP status or eligibility would be a distinct advantage.

Main Purpose:

To provide key support to the Head of Quality in all matters relating to the provision of technical delivery of client projects. The person will take on full responsibility for managing QA activities relating to delivering of client projects and maintenance of the Quality System at our client and to ensure that the operational business is in compliance with GMP. 

Principal Responsibilities:

    • 1. Management of quality systems including but not limited to:

    • o Deviations

    • o CAPA

    • o Change Control

    • o Audits

    • o Customer Complaints

       

    • 2. Be responsible for review and approval including but not limited to the following documents:

    • o Failure investigations

    • o Change control documents

    • o Corrective/preventative action documents

    • o Standard operating procedures

       

    • 3. To maintain electronic databases; for example, Change Control and Deviation Management.

    • 4. Manage preparation of batch doc files and issues arising to facilitate batch release in a timely manner to meet client requirements.

    • 5. Development and approval of procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.

    • 6. To provide monitoring and trending metrics associated with company quality systems.

  1. 7. Actively participate in continuous improvement initiatives.

  2. 8. Participate in regulatory and customer audits as required.

  3. 9. Collaborate with contract parties to resolve issues and maintain compliance.

  4. 10. Identify gaps in systems and develop feasible plans for correction.

  5. 11. Manage and participate in internal audit schedules as per the agreed plan.

  6. 12. Manage and drive supplier qualification activities ensuring Approved Supplier Lists are maintained.

  7. 13. Co-ordinate and manage Product Quality Reviews and proactively identify any areas where compliance gaps or significant negative trends may exist.

    Project Delivery

  • • To plan and deliver all client projects, to meet technical requirements and to ensure the completeness of project plans, correct allocation & implementation of timelines and project costings. To ensure all personnel are aware of their responsibilities and to monitor progress against key milestones / activity dates and report on progress to the HOQ and Project Team.

    Technical

  • • To undertake ongoing Continuing Professional Development (CPD) to ensure currency of technical knowledge and skills.

    Communication

  • • To prepare company publications example web news & technical articles and e-Newsletter.

    Customer Service

  • • To deal with internal/external customer contacts and resolve queries and problems in an effective manner 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 our clients’ company.

    Compliance

  • • To ensure compliance with all inter company policies and procedures, including Quality Systems.

  • • To ensure all documentation prepared is in line with standards as set down by relevant Legal and Regulatory bodies.

PERSON SPECIFICATION: Qualifications / Experience

 

❖ 3rd Level Qualification in Science or Quality Management

❖ Minimum of 10 years’ experience in GMP, preferably in sterile and biotech drug products., encompassing Quality Management or Compliance role.

❖ High level Computer Literacy and competency – Microsoft Office, Microsoft Project.

❖ QP Status / QP Eligibility (Preferably)

 

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 client 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.

Resilience - The capacity to make realistic plans and take steps to carry them out. A positive view of yourself and confidence in your strengths and abilities. Skills in communication and problem solving. The capacity to manage strong feelings and impulses.

Emotional Intelligence - The ability to identify, use, understand and manage emotions in positive ways to relieve stress, communicate effectively, empathise with others, overcome challenges and defuse conflict.

Flexibility - Ready and able to change so as to adapt to different circumstances

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, builds and establishes rapport with customers, clients and other service providers of our client.

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.

An excellent salary and benefits package will apply to the right candidate.

For further information, please contact Paul Flanagan immediately at Dublin (01) 805 5522 or e mail your c/v in the strictest confidence to paul@pharmasolutions.ie

 

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