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The Senior Quality Specialist, Quality Operations 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. 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. Supports implementation and/or recommends internal/external business or compliance options and best practices to improve products, processes or services. 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. Assists in decision making that requires developing options to solve moderate to complex issues. May lead operational teams in the development, management, harmonization, and improvement of quality systems and procedures.
Key Accountabilities
Quality Documentation/Reports Review
* Contributes to preparation and/or review of annual product review and updates for regulatory filing(s), batch release metrics, and department reporting as applicable.
* 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 CMO.
* 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.
Qualifications
* Bachelor’s degree in a scientific related field with a minimum of 5-8 years’ relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry.
* Master’s degree in above fields with 3-6 years’ relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry OR
* Technical and quality background related to the sciences.
* Background in sterile manufacturing 1-5 years
Knowledge
* Strong knowledge of all current state, federal, and local US and EU standards and regulations (ICH, EU GMPs, US CFRs, ISO, etc.).
* Knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines.
* Strong knowledge of the principles, concepts and theories of the compliance/QA discipline.
Skills and Abilities
* Strong verbal and communication skills required.
* Demonstrated excellent interpersonal skills and flexibility.
* Ability to handle multiple priorities in a fast paced environment.
* Strong organizational skills.
* Ability to build peer relationships.
Physical Requirements
* Routine office work (sit/stand);
* International Business travel up to 20%.
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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