Senior Quality Specialist NPI

Team Horizon is seeking a Senior Quality Specialist on an initial 12-month contract. 

This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. This will involve partnering with major stakeholders such as Manufacturing, QC, QPs, Technical services, Engineering and Planning to optimize patient supply.

Why you should apply:

• Join a team who unleash bold thinking with the power to inspire life-changing medicines.


• Hybrid role with a mix of in-person working to give a platform to connect, work at pace and challenge perceptions with balance of remote working 2 days per week.

What you will be doing:

• Quality Oversight for new product introduction in Bulk Drug Substance facility.


• Quality oversight for new or modified facilities, equipment, technologies, including analytical, as well as other continuous improvements and requalification’s.


• Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating manufacturing


• Review and Approve project documents involving cross-functional, multi-departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, Equipment and others.


• Review and approval of qualification/verification/validation documents for facilities, equipment, processes, analytical methods, suppliers, software and others. (e.g. URS, Facility, Utility, IT Systems, Test Methods, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures.


• Quality oversight on operations and technical services to review and approve Process descriptions , sampling plans, operational procedures, process validation and cleaning validation documents


• Review and Approve TRA’s, MSRs, SAP requests related to new products .


• Provide QA support for supplier qualifications.


• QA review all analytical facility, equipment and method qualifications and validations.


• Ensure all Materials are sampled and released as per the approved specifications and procedures .


• Investigation and approval of deviations generated encountered during qualification/validation testing.


• Participation in the project change control program and deviations for modifications to new and existing systems. equipment.


• Provide guidance to project teams on Quality regulations for Validation strategy and approach.


• Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk


• Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Commercial Operations groups.


• Provide sound QA and Compliance support to manufacturing, engineering, automation, utilities, supply chain, and material movement and laboratories.


• Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.


• Actively support audit readiness activities and regulatory agency and internal audits.

What you need to apply:

• Third level qualification e.g. B.Sc. in science/pharmacy or equivalent with a minimum of 6-8 years’ experience in cGMP Quality environment


• Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.


• Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing.


• Excellent accuracy and attention to detail


• Good knowledge of relevant computer packages e.g. Delta-V, Veeva vault or similar


• Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.


• High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management.


• Previous QA experience aligned to Technical Services, Engineering/CQV reviews, operational (batch records, procedures), supplier qualification, packaging lines, warehousing (including temperature mapping of, along with fridges and freezers) and QC analytical qualifications/validations and laboratories of particular interest.


• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written