Order Operations Specialist
MarketStar
ERP
Manager, Quality Operations, QP Team
Bristol Myers Squibb
full-time
Posted on:
Location Type: Hybrid
Location: Dublin • 🇮🇪 Ireland
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
React
About the role
- Support the Qualified Person with the Batch Certification function
- Prepare and review of batch documentation packages for QP release as per SOP requirements
- Communicate and collaborate with BMS Supply Chain to support QP release schedule, as required
- Complete activities associated with new product introductions
- Authoring, review and approval of QA-related procedures and relevant controlled documents.
- Provide training to new team members, as required
- Support the site inspection readiness program for corporate and regulatory inspections and act as SME, when required
- Preparation of quality documents supporting batch certification e.g., QP declarations, Product Quality Reviews and Risk Assessments
- Act as functional lead for QMS activities e.g., Change Control assessments, Investigations and Quality Agreement updates.
- Perform additional team tasks as agreed to support effective running of the function
- Support Opex programs and champion continuous quality improvement initiatives
- Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
Requirements
- BSc in Science or related discipline with 2-3 years QA experience in a pharmaceutical environment, preferably Operations based.
- A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
- Demonstrated proficiency communicating and collaborating at a variety of levels and across divisions
- Demonstrated ability to recognise issues, highlight risks and prioritise workload based on schedule requirements
- Proven success working well in a team environment with flexibility to react to changing business needs
- QP Eligible (Desirable)
Benefits
- Competitive salary
- Annual bonus
- Pension contribution
- Family health insurance
- 27 days annual leave
- Access to BMS Cruiserath on-site gym
- Life assurance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
batch certificationQA proceduresquality documentsrisk assessmentschange controlinvestigationsquality agreementsOpex programscontinuous quality improvement
Soft skills
communicationcollaborationissue recognitionrisk highlightingworkload prioritizationteamworkflexibility
Certifications
BSc in ScienceQP Eligible