QA Compliance Specialist (Part-time)

Sligo
Permanent
Part-time

1 month ago

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , , and .Job DescriptionWe 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 non-compliances.
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 risk-based, compliant decisions on change controls, validation and policy implementation.
Manage day-to-day compliance queries and escalate significant issues as required.
Influence product quality and manufacturing performance through effective quality system oversight.

Qualifications

Third-level 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 InformationAbbVie 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, visitUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:Recruitment Fraud AlertWe have recently become aware of various recruitment phishing scams targeting job seekers. Please be advised:

AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.

If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please immediately.Protect yourself by verifying job offers and communications. Your safety is important to us.Pay Range: $-Where We WorkRole is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.Share this job:

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