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Quality Officer – 1 Year Maternity Cover (Contract)

Dublin, Ireland

Description

Quality Officer – 1 Year Maternity Cover

APC Ltd is an award-winning and rapidly growing science and technology-driven pharmaceutical process research company.  In the space of 5 years, we have pioneered innovation in the sector and we now partner with 8 of the top-10 pharma and 5 of the top-10 biotech firms in the world. 

From our world-class facility, we offer specialised chemical and process engineering solutions.  Powered by novel technology and world-class scientific research, we help companies accelerate the development & launch of their medicines. Our rapid growth has come from a commitment to excellence, a drive to innovate and the desire to develop a challenging, creative and rewarding environment for our team. 

APC is currently looking to appoint a Quality Officer to be part of this rapidly growing organisation.

About the Team

Department:    Technical Operations

Reports to:       Quality Assurance Lead

Our Quality Team comprises seven highly qualified, capable and welcoming colleagues. We are responsible for ensuring that the technical processes meet the highest Quality standards. The Quality team, both individually and collectively, offer support to the wider Technical Operations teams, confirming APC meets the client’s expectations. We are responsible for maintaining compliance in processes and procedures.

Our team vision is to support the excellence of the project teams by providing Quality oversight and ensuring a high level of awareness is maintained.

Role Purpose

Responsible for ensuring that the technical processes meet the best in class Quality standards through provision of Quality support to APC Technical Operations ensuring a high standard of awareness, understanding and compliance of Quality SOPs and processes.

Key Responsibilities

Quality Management System

  • Develop, enhance and maintain the Quality Assurance programme to meet best in class standards.
  • Enhance the regulatory understanding and capability of the team.
  • Ensure the organisation meets its statutory obligations in all Quality areas and supports the fostering of a workplace which focuses on ‘right first time’.
  • Ensure all SOPs, forms, logs, protocols and summary reports are completed and reviewed against Quality standards.  Issue laboratory notebooks and equipment logbooks as required.
  • Support the development and implementation of QMS programme across the organisation. 
  • Identify and implement training to ensure efficient and effective completion of all Quality related training.
  • Ensure that all quality SOPs and programmes are adhered to and are regularly reviewed, updated and communicated.
  • Prepare Quality compliance metrics as required.
  • Ensure that all CAPAs and deviations are documented, investigated and recommended improvements implemented.

Audit Readiness & Continuous Improvement

  • Provide subject matter expertise to Technical Operations on various Quality related topics.
  • Support any external Quality audits with co-ordination of audit activities and action plans. 
  • Conduct internal Quality audits e.g. walk through audits, system audits, report issuance, CAPA follow-up and closure.  Ensure that follow-up actions are completed.
  • Ensure compliance of Quality and use analytics to measure compliance across the organisation.
  • Establish a structured programme of Quality training across the organisation and ensure accurate training records are maintained.
  • Facilitates ‘as is’ mapping and root cause analysis.  Use continuous improvement tools to instigate actions for improvements.
  • Adhere to business processes as required.

Collaboration & Engagement

  • Provide Quality oversight for assigned projects within Technical operations.  Actively participate in projects by attending meetings (internal and external) and project updates, perform quality review of laboratory notebooks, technical data and the final technical reports.
  • Contribute to and participate in the After-Action Review (AAR) meetings.
  • Prepare and deliver quality training materials to colleagues.
  • Share information, suggestions and observations to create consistency in Quality standards across the organisation.
  • Collaborate with HR and Training on LMS and training activities. 
  • Participate in relevant forums e.g. QMS/SMS, training, equipment as required to improve awareness of Quality.

Key Competencies

  • Excellent organisational skills and ability to prioritise.
  • Flexible and be able to adapt within a changing environment.
  • Excellent communication skills with the ability to work cross-functionally.
  • Excellent oral and written communication and planning skills.

Required Experience

  • Required: Degree level or equivalent in life sciences.
  • Desirable: Inclusion of Quality related subject in qualification.
  • 2-3 years’ experience working in the pharma/biopharma industry or R&D environment.
  • Good working knowledge of implementing and using continuous improvement tools.
  • Experience with implementation of corrective action programmes.
  • Experience of development, implementation and management of Quality Management systems.

 Skills & Knowledge 

  • Good working knowledge of MS Office.
  • Excellent technical report writing skills.
  • Excellent attention to detail.
  • Ability to work autonomously or as part of a diverse team.
  • Regulatory experience in a GMP environment would be advantageous

How to apply

Suitable candidates should submit a CV and a Cover Letter by close of business, Monday 16th September 2019.

The salary is negotiable and dependent on the experience of the successful candidate.

APC is committed to the principle of equal opportunity for all employees. All employment decisions at APC are based on business needs, job requirements and individual qualifications, without regards to gender, ethnicity, age, religious belief, disability, sexual orientation, gender identity and/or expression, or any other status protected by Irish Law.

Similar vacancies arising in the coming 6 months may be filled from this group of applicants.

 

Salary

Negotiable