Job Description
Our client is a multinational biopharmaceutical company with an outstanding track record of innovation in their specialist therapeutic sector. This role is a unique opportunity at a development-stage company, with field-leading advisors, and a highly experienced technical/operational team.
We are looking for an experienced Quality Assurance Technical Specialist to support the implementation, training and continued management of Good Regulated Practice (GXP) quality assurance associated tasks. Reporting directly to the Senior Director of Project and Vendor Management the Quality Specialist will work within the project teams and support internal and external project quality related tasks. The role will also involve close collaboration with Quality Management Consultant to support ongoing development, implementation, and maintenance of the quality system.
Job Spec
To support development, facilitation and maintenance of the Quality Management System (QMS)
To participate in quality assurance projects and continuous improvement activities across all GXP
To conduct, attend and contribute to external GXP audits
To support tracking and resolution of GXP corrective/preventative actions (CAPA) and associated commitments.
To assist in monitoring of legislation, guidelines and the national regulatory environment to maintain GXP intelligence and awareness of compliance and best practice within the company
GXP Quality Management
- Act as a GXP Quality point of contact for internal and external contacts
- Ongoing maintenance of the GXP Quality controlled document system, including SOPs, procedural documents and any associated forms and templates
- Working with Process Owners to provide guidance on the creation of SOPs and procedural documents
- Assist with conducting quality and compliance reviews of new and updated procedures
- Provide support for the development of training materials for new and updated procedures
- Support the review and update of all GXP procedures within the company-defined review periods
- Maintain good awareness of current legislation, regulatory guidance and company policies to ensure these are reflected in GXP procedures
- Identify opportunities for continuous improvement of processes for GXP related activities
- Identify process efficiency/effectiveness issues and help in facilitating solutions for improvement
- Provide support for GXP quality verification and oversight including support for development of corrective action plans for activities not meeting quality standards
- Support Operations teams for development and implementation of Quality Plans
- Support and maintain quality activities for oversight of vendors, suppliers and subcontractors to ensure they are functioning appropriately; attend and support audits as required
- Review and approve GMP related documentation generated by GMP suppliers
- Support GXP QMS change control activities, and update of CAPA tracking systems
- Support GXP teams in the conduct of root cause analysis of quality issues
- Quality representative at Team meetings, project and programme meetings as applicable
Audits & Inspections
- Attend and support of internal and external supplier audits
- Tracking and follow-up of internal and external GXP audit and inspection findings
- Support the preparation of appropriate metrics and key performance indicators (KPIs) to demonstrate GXP compliance levels.
Quality Culture
- Support the Quality Management Consultant’s work to continuously educate the applicable departments on the importance of quality management & facilitate the implementation of best practices
- Champion the implementation of best practice in Quality in Technical Operations and support continuous improvement activities.
Records Management
- Work with the responsible individuals to ensure appropriate records retention for all GXP Quality documentation
- Support and facilitate good documentation practices within the Technical operations teams.
- Support the compilation of documentation to support Regulatory submissions
Compliance Training
- Support, maintenance and improvement of GXP quality and compliance training programs.
- Assist with training of teams and associated third parties on GXP related Regulations, Quality & Compliance
Person Spec
Experience includes but is not limited to:
- Bachelor’s or higher graduate degree in a science related field, or equivalent experience
- Formal training in quality assurance; a professional qualification in quality &/or auditing would be advantageous
- Experience working with the quality systems associated with drug development / Medical devices or similar technologies is an advantage
- Proven experience within a quality role
- Strong knowledge of the quality management principles
- Experience of conducting audits and quality reviews
- Experience with developing SOPs and department processes
- Experience with training and mentoring staff
- Proficient in Microsoft Office
- Effective oral and written communication skills in English
- Deadline-driven, pro-active approach
- Process orientated with outstanding attention to detail
- Solution orientated with an ability to lead teams and influence at all levels
- Excellent organisational and interpersonal skills
- Ability to interact with key stakeholders including external clients
Cv to gerry@rftgroup.ie