Senior QA Specialist
A key member of the team, responsible for the successful day-to-day running of the Quality Operations and Quality Management System (QMS) for the facility, as well as supporting other organizational objectives.
Key Responsibilities:
* Represent Quality during manufacturing operations, resolving issues and providing guidance in a collaborative fashion.
* Provide operational quality support for production, ensuring the manufacture of quality products in accordance with product licenses and filings.
* Perform production on the line AQLs, and the incoming inspection and disposition of raw materials, consumables, packaging.
* Review manufacturing-related documents (e.g. Specifications, Batch Records, Validation data, QC data, etc.) in accordance with the facility requirements.
* Implement and oversee the quality systems (change controls, deviations, etc.), ensuring compliance with all relevant regulatory guidelines and policies.
* Provide quality and cGMP input and oversight of the manufacturing facility, including data integrity.
* Manage and support the facility Supplier Management program, including qualifications and re-qualifications of suppliers and materials, auditing vendors, and providing oversight as required.
* Generate Quality Systems metrics and prepare presentations suitable for Senior Management review.
* Generate and approve Quality documents (e.g. Annual Product Reviews, License variations, etc.).
* 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 program, performing internal audits, training internal auditors, and implementing audit action plans.
* Participate in third-party audits and/or 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.
Requirements:
* 4-7 years' experience working 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.
* Highly flexible, works well in a team environment, and has necessary skills to organize, communicate, influence, and lead.
* Demonstrated capability in establishing collaborative working relationships at all levels.
* Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems.
* Ability to work independently, as well as a member of a team, in a dynamic, fast-paced environment.
* Ability to deliver objectives on time, meeting all compliance and cost targets.
* Ability to generate documentation of high standard.
* Possess good organizational skills and attention to detail.
* Ability to handle and prioritize multiple assignments, changing priorities, and meet deadlines.
Preferred Requirements:
* Demonstrated expertise in Data Integrity highly desirable.
* Working experience in SAP and LIMS highly desirable.
* Experience in participation in regulatory audits highly desirable.
Education and Licenses:
* BSc in science discipline required.
* Lead auditor certification highly desirable.
* Qualified Person experience or educational requirements desirable.