Job Description Summary
Review of Analytical documents of Raw materials, packing materials, In process, Hold time, finished product, stability, Analytical method transfer/Validation/Verifications protocol, reports, and raw data.
Review and approval of Specifications for API, Excipients, packing materials, in process, finished product and stability.
Review of qualification documents (IQ/OQ/PQ) of equipment’s/instruments.
Investigation and review reports of laboratory OOS, OOT, Incidents. Discussion of QMS action points with CFT and to make sure the closure within TCD.
Provide support in assessing Change Control requests. A
Computer System Validation (CSV) deliverable preparation/review.
Audit trail review of laboratory insruments.
Handling of Change control, CAPA.
Job Description
Review of Analytical documents of Raw materials, packing materials, In process, Hold time, finished product, stability, Analytical method transfer/Validation/Verifications protocol, reports, and raw data.
Review and approval of Specifications for API, Excipients, packing materials, in process, finished product and stability.
Review of qualification documents (IQ/OQ/PQ) of equipment’s/instruments.
Investigation and review reports of laboratory OOS, OOT, Incidents. Discussion of QMS action points with CFT and to make sure the closure within TCD.
Provide support in assessing Change Control requests. A
Computer System Validation (CSV) deliverable preparation/review.
Audit trail review of laboratory insruments.
Handling of Change control, CAPA.
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.
Community Guidelines:
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• Comments that use profanity; personally attack or bully another individual; or are off-topic, misleading, factually inaccurate, political, spam, defamatory, discriminatory or promotional.
• Comments that are excessively repetitive and/or disruptive to the community.
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• Comments that appear to be medical advice.
We reserve the right to remove a reply for any reason at any time.
3. Adverse Event Reporting: If we see a post about an adverse event, an Endo representative will need to contact you to find out more information to comply with regulatory guidelines. If you experience a side effect while using an Endo product, please consult your physician or pharmacist immediately. You may also report to the FDA at fda.gov/medwatch or 800-FDA-1088.
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