Job Description Summary
To review and ensure that all data generated from Analytical Laboratory are accurate, Complete and in compliance with data integrity, current Good Laboratory Practices(cGLP) and regulatory agency requirements. Maintains quality and compliance by identifying quality requirements, disseminating standards, policies and procedures.
Job Description
- Timely review of Analytical data for accuracy, completeness and compliance to data integrity, written procedures and cGLP regulations.
- To ensure timely review of the computerized system Audit trails, Electronic Data Management and closure of the review comments.
- Support ARD department for the timely closure of Quality Audit observations and to define appropriate CAPA for the same.
- Ensure compliance with internal approved procedures, SOP’s and protocols of all generated data.
- Timely initiate change control, CAPA, incident, deviations, and perform investigations and ensure timely closure of QMS records.
- Review of Qualification and related Documents for adequacy.
- Participate in continuous improvement initiatives relates to quality activities.
- To prepare and review Standard Operating Procedures as per Lab requirement.
- Perform other related duties as may be reasonably assigned in course of business.
- Knowledge of Computer System Validation and Excel sheet validation.
- Strong knowledge in analytical software’s like Empower, Veeva QualityDocs, Track-wise etc.
Education & Experience:
- Master of Pharmacy or Master of Chemistry (Full Time).
- Required Experience: 9-12 yrs. of Analytical research and development, DQA or compliance experience for regulated market.
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.
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.
Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.
Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.
Endo has global headquarters in Malvern, Pennsylvania.
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