Analytical Quality Specialist

Desired Skills: Quality Control,QC Laboratory,GMP,API,CMO collaboration,QMS.

Responsible for supporting analytical testing related to RSM, Intermediate, API and Drug Product manufacturing in an external manufacturing environment, collaborating with Contract Manufacturing Organizations (CMOs), managing Contract testing laboratories (CTL’s) linked to external manufacturing and working within Virtual Plant Teams (VPTs)

Responsibilities:
•Provision of analytical expertise and troubleshooting support in the areas of Pharma for the external manufacturing environment
•Engage with internal and external stakeholders to plan and manage all testing of Pharma products at contract testing laboratories and CMOs
•Serve as analytical contact for CMOs and CTLs (associated with ExM), addressing analytical issues and requests while coordinating with relevant stakeholders.
•Review and approve laboratory investigations, deviations, and out-of-specification (OOS) events at CMOs and CTLs in partnership with method subject matter experts. Provide technical support to the Qualified Person (QP)/ Responsible Person (RP) and Quality Operations in relation to same
•Act as Lead Investigator for major analytical deviations, managing Infinity records as required.
•Review and approve analytical change controls from CMOs and CTLs, and assess the impact of change controls related to CMO/CTL analytical testing.
•Initiate change controls for analytical changes impacting CMOs and CTLs.
•Manage communication between CMO/CTL analytical teams and global functions such as Global Testing Standards, the Reference Standards Management Team (RSCR), Global Quality Control Strategy & Analytical Science, and the Microbiology Centre of Excellence.
•Oversee method and specification update communications to CMOs and CTLs.
•Ensure timely supply of reference standards and critical reagents necessary for CMO/CTL testing.
•Support internal and external audits as the Quality Control (QC) laboratory subject matter expert.
•Liaise with the Global Stability team and VPT’s concerning CMO stability programs.
•Prepare sample submission forms for CTL testing(as required), and monitor sample shipments, receipt, testing, and release status as needed.
•Support the team with analytical technical transfer activities to CMOs and CTLs as required.
•Support the team with the review and approval of analytical method validation, transfer, and verification documentation/activities at CMOs and CTLs to ensure compliance with International Council for Harmonisation (ICH) guidelines and manage gap analysis remediation both within the company and CMO/CTL sites.
•Support review of sample plans, Annual Product Quality Reviews (APQRs), risk assessments, quality agreements, etc. •Facilitate coordination of data requests from CMOs and CTLs.
•Assist with analytical components of regulatory submissions as required.
•Support Procurement with the Request for Proposal (RFP) process.

Education:

• Minimum B.A. or B.Sc. in life sciences
• Experience/Knowledge:
• 3-5 years’ experience in GMP QC environment
• Ability to work independently and within team matrix environments
• Thorough knowledge of worldwide regulatory Good Manufacturing Practices (GMP) requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements
• In depth knowledge of Quality Management Systems relating to laboratory operations
• Ability to ensure objective critique of analytical investigation reports from CMOs or CTLs
• Previous experience in QC laboratory is highly desirable
• Previous experience using electronic document and deviation management systems is desirable
• Working knowledge of analytical technical transfers is desirable

  Skills/Competencies:

• In-depth knowledge and operational experience in a Pharmaceutical QC laboratory
• RSM, Intermediate, API and Drug Product Pharmaceutical testing experience
• Knowledge of analytical technical transfer processes, compliance requirements and proven troubleshooting skills
• Project Management skills are required
• Management of Third Party relationships (desirable)

Please click the link below to apply or alternatively send an up-to-date CV to howie.leahy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***