QA Compliance Specialist (Part-time)
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Job Location:
Monthly Salary:
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
We are recruiting a part time QA Compliance Specialist to join our team at AbbVie Manorhamilton Road Sligo. The QA Compliance Specialist is responsible for maintaining and improving the site quality system to ensure full compliance with GMP HPRA/FDA and AbbVie quality requirements. The role includes assessing the effectiveness of the quality system and reporting outcomes to senior management. This role is a 6 month role.
Key responsibilities
- Own and maintain the site quality system ensuring compliance with regulatory and AbbVie requirements.
- Lead and support regulatory inspections and requests including preparation logistics and responses.
- Support Quality Risk Management (RCS FMEA) and internal GMP audits.
- Initiate and close out quality events/records (ERs) and drive resolution of quality system noncompliances.
- Provide QA and validation support including review/approval of validation and change controls.
- Monitor and report quality system performance at management and quality review meetings.
- Ensure site personnel understand and follow quality cGMP and policy requirements.
- Adhere to and promote EHS & E standards.
Decision making and scope
- Make riskbased compliant decisions on change controls validation and policy implementation.
- Manage daytoday compliance queries and escalate significant issues as required.
- Influence product quality and manufacturing performance through effective quality system oversight.
Qualifications :
- Thirdlevel qualification in a Science or Quality discipline.
- Minimum 3 years experience in a pharmaceutical or sterile manufacturing environment.
- Strong knowledge of GMP quality systems and regulatory expectations (HPRA/FDA).
- Strong written and verbal communication skills.
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:
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Employment Type :
Part-time
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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
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