The Senior QA Specialist plays a vital role in ensuring the successful day-to-day operation of Quality Operations and the Quality Management System (QMS) at the facility. This position supports organizational objectives and is responsible for operational and compliance support for manufacturing operations, maintaining site compliance programs, and managing supplier qualification programs.
Key Responsibilities:
* Represent Quality during manufacturing operations and provide guidance to resolve issues collaboratively.
* Provide operational quality support for production, ensuring the manufacture of quality products in accordance with product licenses and filings.
* Perform production AQLs, incoming inspection, and disposition of raw materials, consumables, and packaging.
* Review manufacturing-related documents in accordance with facility requirements.
* Implement and oversee quality systems, ensuring compliance with relevant regulatory guidelines and company policies.
* Provide quality and cGMP input and oversight of the manufacturing facility, including data integrity.
* Manage and support the facility's Supplier Management program, including qualifications, re-qualifications, auditing vendors, and providing oversight as required.
* Generate Quality Systems metrics and prepare presentations for Senior Management review.
* Generate and approve Quality documents, such as Annual Product Reviews and License variations.
* Support validation activities, reviewing and approving technical support documentation.
* Manage a QMS system to ensure compliance and adherence to site metrics.
* Manage QA responsibilities of external manufacturers of APIs, reviewing deviations and changes at the CMO site.
* Support site compliance programs, performing internal audits, training internal auditors, and implementing audit action plans.
* Participate in third-party audits and inspections carried out at the site by authorities or clients.
* Partner with other SMEs to understand and proactively respond to changes in the regulatory environment and coordinate quality involvement as required.
* Lead and support initiatives and action plans for QA development and GMP compliance improvement.
Required Knowledge, Skills, and Abilities:
* 4-7 years' experience in finished product pharmaceutical/biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
* Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs, and ICH guidelines.
* Flexibility, teamwork, organization, communication, influence, and leadership skills.
* Collaborative working relationships at all levels, strategic thinking, and problem-solving ability.
* Ability to work independently and in a team environment in a dynamic, fast-paced setting.
* Delivering objectives on time, meeting compliance and cost targets, and generating high-quality documentation.
* Good organizational skills, attention to detail, and handling multiple assignments and changing priorities.
Preferred Knowledge, Skills, and Abilities:
* Demonstrated expertise in Data Integrity.
* Working experience in SAP and LIMS.
* Experience in participating in regulatory audits (HPRA or FDA).
Education and Licenses:
* BSc in science discipline required.
* Lead auditor certification desirable.
* Qualified Person experience or educational requirements desirable.