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Endo Pharmaceuticals

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4.6

based on 9 Reviews

20 Endo Pharmaceuticals Jobs

Deputy Manager, Analytical (Documentation)

Endo Pharmaceuticals

4.6

based on 9 Reviews

10-13 years

Kolkata

1 vacancy

Deputy Manager, Analytical (Documentation)

Endo Pharmaceuticals

posted 4mon ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy Analytical Chemistry Equity Research Training Compliance Document Review

+ 4 more

Job Description

Job Description Summary

Oversight of Analytical laboratory functions for laboratory documentation and
establishment of departmental objectives consistent with company goals.

Job Description

Job Description :-

Direct oversight of laboratory functions for laboratory documentation and establishment of departmental objectives consistent with company goals.
Daily work allocation to the team members. To monitor and ensure correctness & completeness in day to day activity.
Documentation review like SOP, Protocol, Report, format, STP, Specification, GTP, work sheet, COA as and when required. Report preparation and compilation of analytical validation/calibration report/records.
Review of Protocol and Reports for method development, method validation for Nitrosamine impurities by LC-MS.
Review of Protocol and Reports for method development, method validation for elemental impurities by ICP-MS.
Review of Protocol and Reports for Method development, method validation for Extractable and Leachable study.
To prepare, review and implement system SOPs to ensure compliance to regulatory requirements and update as required.
Responsible to take up additional responsibility allotted by the supervisor and to fulfill the same.
Responsible to initiate Change control, incident, deviation, investigations, OOS and OOT etc. FAA for Compliance wire and responsible for training coordination.
Responsible for Documentation of Raw material verification and release activity.
Responsible for review of documents like Method transfer protocol and reports, Method validation/verification protocol and reports.
Co-ordination with cross functional teams for method transfer, Co-ordination with QA for submission of analytical data, COA and reports. Co-ordination with compendial review Team for pharmacopeial updation.
Responsible for imparting training to the employees. Responsible for creation of Specification and methods in Global formats, Co-ordination with Global team for harmonization of specification and methods in global format

Education and Experience: -

Masters in science /Pharma with 10 to 13 years relevant experience.

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.

Employment Type: Full Time, Permanent

Read full job description

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