MQA Lead
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Join AbbVies Quality Assurance team as an MQA Lead at our Biologics facility in Ballytivnan Sligo. You will play a key role in ensuring that our marketed and investigational drug products meet global standards providing quality oversight and guidance for aseptic manufacturing operations in a highly regulated environment.
Responsibilities
- Ensure all products meet requirements for patients regulatory authorities and the company.
- Provide quality and compliance oversight to operations supporting aseptic production and intervention observation.
- Lead investigations into product or manufacturing process non-compliance issues.
- Guide train and support shift team members in decision-making.
- Review and audit batch records manufacturing logs and operational SOPs.
- Perform line clearance raw material checks and maintain product status as required.
- Lead GEMBAs of manufacturing areas and drive continuous improvement.
- Act as SME for quality issues during shift operations.
- Uphold all cGMP HPRA/FDA and EHS standards.
Qualifications :
- Third-level degree in science quality or engineering.
- Minimum 3 years experience in quality/operations in a GMP-regulated environment (biologics preferred).
- Experience in aseptic processing highly desirable.
- Excellent written/verbal communication and interpersonal skills.
- Demonstrated experience in regulatory inspections
- Proven knowledge of regulatory requirements and strong problem-solving communication and interpersonal skills.
- Previous experience as a trainer
- Commitment to quality attention to detail and Right First Time ethos
- Previous leadership experience
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Administrative Skills
- Facilities Management
- Biotechnology
- Creative Production
- Design And Estimation
- Architecture
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
