QA Lead Investigator

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QA Lead Investigator (FTC 12-14 months)

Location: Craigavon

Hours: 37.5 Hours per week

Salary: Competitive

Business Unit: Clinical Services

Open To: Internal and External Applicants

Ref No.: HRJOB9729

The Role

The role of the QA Lead Investigator is crucial in maintaining the Quality Management System and driving continuous improvement within the organization. The main objective of this role is to investigate deviations and incidents, implement corrective and preventive actions, and collaborate with multiple stakeholders to prevent re-occurrence. The responsibilities of the QA Lead Investigator include conducting investigations, performing root cause analysis, reviewing and approving quality event reports, participating in customer teleconferences, conducting trend analysis, suggesting process improvement initiatives, monitoring the status of quality events, and ensuring compliance with GMP principles and internal SOPs.

The post holder will also be responsible for collaborating with personnel involved in the incidents, evaluating the impact and risk, and determining root cause and contributory factors through root cause analysis tools. They will also be involved in raising incidents within the system, organizing critical call meetings, providing guidance on investigations, ensuring high-quality reporting, monitoring timelines and commitments, responding to customer queries, and assessing the adequacy of CAPA close-out.

Additionally, the QA Lead Investigator will assist management in preparing data for review meetings, updating quality indicators, conducting trend analysis, and completing necessary administrative duties. It is essential for this role to maximize efficiency through effective time management and prioritize daily activities independently. Regular communication and collaboration with other Lead Investigators are also expected, focusing on identifying opportunities for business improvement and process simplification.

Key Requirements

· Have eligibility to work in the UK OR possess a valid work permit that will allow you to take up full time, permanent employment in the UK

· Degree level (or equivalent) qualification

· Experience in the production and presentation of reports

· Experience in the analysis of data within Excel (or related software)

Desirable Requirements

· Degree level qualification in a scientific, business or engineering disciplines

· Previous involvement in continuous improvement initiatives

· Previous experience with Root Cause Analysis Techniques and technical writing

· Previous experience in the Pharma industry

· Experience using Veeva-Vault system

Further Information

This role is based on a full flex working pattern of 06:00 – 19:00 with a minimum 5 hours per day. This role will also be eligible for hybrid working following the successful completion of probation (1 day from home/4 in the office).

Apply Now

Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.

Closing Date

We will no longer be accepting applications after 5pm on 29 May 2024

RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CV’s received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

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