Job Description Summary
1.Responsible for preparation and review of Analytical method validation protocols for MLT, BET, Sterility, Container Closure Integrity Testing, Bioburden and other Microbiological methods.
2.Responsible for sample management, media and culture management including Microbial Identification on Vitek System.
3.Responsible for Maintaining Laboratory Analytical review of Documents and timely submission of Laboratory documents for Archival.
4.Trouble shooting and supervision of team members involved in sample management, media and culture management related testing activities.
5.Responsible for maintaining, reviewing and evaluation of GLP compliance in laboratory and take effective measures as a continuous improvement program.
6. Execution of BET by KTA and Gel-clot method, Particulate matter testing.
Job Description
1. Responsible for Microbiology operation and implementation of approved procedures in Laboratory.
Responsible for sample management, media and culture management.
2.Responsible for preparation and review of Analytical method validation protocols for MLT, BET, Sterility, Bioburden and other Microbiological methods.
3.Responsible for Maintaining Laboratory review of Documents and timely submission of Laboratory documents for Archival.
4. Ensure timely completion of method validation of all the samples.
5. Coordinate with cross functional team for planning and effective execution of Method Validation activities and support manufacturing related activities in Microbiological studies.
6.Responsible for maintaining, reviewing and evaluation of GLP compliance in laboratory and take effective measures as a continuous improvement program.
7. Trouble shooting and supervision of team members involved in sample management, media and culture management related testing activities.
8.Review and submission of document to regulatory department for filling and regulatory approvals.
9.Support and participate in internal, customer and regulatory inspection and ensure appropriate CAPA initiated and implemented.
10.Evaluate and approve change control, deviations and CAPA raised by Microbiology department and other departments and identify actions to be implemented.
11.Ensure monitoring of utilities required for manufacturing process as per approved schedule and carryout data trending and analysis.
12.Participate in quality improvement programs and support QA function to execute quality related projects.
13. Prepare departmental budget and maintain adequate inventory of consumables.
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:
1. Be respectful. Everyone who visits our page should feel comfortable and respected.
2. If we see a comment that violates anything in the following list, it may be removed.
• 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.
• Comments that promote illegal activity, use copyrights or trademarks or are related to an ongoing legal matter.
• 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.
Replies from other users do not necessarily reflect the views of Endo. We do not endorse content added by other users.
