Job Description Summary

This position will be responsible for Technical Services –Technical support to Site transfer of injectable products. To co-ordinate with all cross functional teams to ensure ‘Sterile injectable product transfer project’ execution within stipulated timelines. Technical support at critical stages of manufacturing during and prior to engineering & Exhibit batches.

Job Description

Broader Role of candidate :

Role would be close Co-ordination with plant QC and Analytical R&D for ensuring readiness of analytical aspect required at ' receiving unit 'for timely & successful accomplishment of transfer of sterile injectable product from R&D or CMO .

Receiving units caters to only US market.

Routine job / responsibility of candidate would be:

specs review, STP review, Nitrosamine risk assessment preparation, Sharing required input to QC for determining elemental risk , theoretical E&L risk assessment, stability protocol review, designing the limits, preparation of protocol for DOE for stability OOS investigation or FP analysis OOS, deciding the sampling stage , tests to be performed and acceptance criteria for hold time samples , PPV samples and consumable product contact compatibility study.

Person from QC analytical /. Lab QA/ Analytical R& D of sterile injectables with 8 to 15 year experience having practical exposure to Minitab, LIMS and trackwise will be preferred.

Educational qualification- B.pharm/ B.Sc/M.Sc/ M.pharm/B.tech.

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.