Senior Quality Specialist

5 months ago

Cork, Ireland Endo Operations Limited Full time

Description

The Senior Quality Specialist, Quality Operations has responsibility for overseeing quality in Contract Manufacturing Quality Operations and Quality Management Systems (all aspects), as well as handling Corrective and Preventive Actions (CAPA). May manage projects or serve as a designee to the Subject Matter Expert (SME) or Process Owner for an internal Quality System.

Quality Documentation Review

Reviews CMO/CPO batch release documentation. Completes release in local SAP system. Escalates any issue that may potentially impact batch release at Endo. Assists with decisions that require developing options to solve moderate to complex issues. Supports implementation and/or recommends internal/external business or compliance options and best practices to improve products, processes or services. Prepares and/or reviews controlled documents (e.g. SOPs) required for compliance. Provides quality guidance on product transfers and validations and will ensure that all activities related to the manufacturing, packaging testing, release and distribution of commercial products meet requirements in the U.S. market and other approved markets.

Quality Systems & Investigations

Takes the lead in resolving investigations, deviations, and corrective actions, and other quality issues with each CMOCPO. Leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities. Contributes to and may lead operational teams in the development, management, harmonization, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and company quality standards in support of cGxP activities. Assists with all aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events.

Inspection Readiness

Participates in cross functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities and special projects.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

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