Job Description:
The Senior QA Specialist is a key member of the team responsible for the day-to-day running of Quality Operations and Quality Management System (QMS) at the facility. This role involves supporting organizational objectives, ensuring operational and compliance support for manufacturing operations, maintaining site compliance programs, and managing supplier qualification.
Key Responsibilities:
1. Represent quality during manufacturing operations, resolving issues, and providing guidance in a collaborative manner.
2. Provide operational quality support for production, ensuring quality products are manufactured in accordance with product licenses and filings.
3. Perform production on-the-line AQLs, incoming inspection, and disposition of raw materials, consumables, and packaging.
4. Review manufacturing-related documents, such as specifications, batch records, validation data, QC data, etc., in accordance with facility requirements.
5. Implement and oversee quality systems, ensuring compliance with regulatory guidelines and company policies.
6. Provide quality and cGMP input and oversight of the manufacturing facility, including data integrity.
7. Manage and support the facility Supplier Management program, qualifying suppliers, auditing vendors, and providing oversight as required.
8. Generate Quality Systems metrics and prepare presentations for senior management review.
9. Generate and approve quality documents, such as annual product reviews, license variations, etc.
10. Support validation activities, reviewing and approving technical support documentation.
11. Manage a QMS system to ensure compliance and adherence to site metrics.
12. Manage QA responsibilities of external manufacturers of APIs, reviewing deviations and changes at the CMO site.
13. Support site compliance programs, performing internal audits, training auditors, and implementing audit action plans.
14. Participate in third-party audits and inspections carried out at the site by authorities or clients.
15. Partner with other SMEs to understand and respond to changes in the regulatory environment.
Required Skills and Qualifications:
1. 4-7 years' experience in finished product pharmaceutical/biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
2. Excellent working knowledge of quality systems, FDA, and EU regulations, cGMPs, and ICH guidelines.
3. Flexible team player with necessary skills to organize, communicate, influence, and lead.
4. Demonstrated capability in establishing collaborative relationships at all levels.
5. Possess fundamental scientific thought processes and ability to apply it to overcome problems.
6. Ability to think strategically and be a 'go-to' expert across the business.
7. Recognize areas for improvement and use initiative to implement change programs.
8. Ability to work independently and as part of a team in a dynamic environment.
9. Deliver objectives on time while meeting compliance and cost targets.
Preferred Skills and Qualifications:
1. Demonstrated expertise in Data Integrity.
2. Working experience in SAP and LIMS.
3. Experience in participation in regulatory audits (HPRA or FDA).
Required/Preferred Education and Licenses:
1. BSc in science discipline.
2. Lead auditor certification.
3. Qualified Person experience or educational requirements.
Sr QA Specialist
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