Job Information
Endo International Technical Services Assistant Manager in Indore, India
Job Description Summary
This position will be responsible for Technical Services –Technical support to Site transfer (from R&D as well as from CMO) 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
Site Transfer of approved products :
Review of TTD documents from SU.
Preparation of product technical presentations and shall be responsible for providing new product training at site.
Preparation and review of Gap Analysis .
Technical evaluation & comparison of COA & specification of RM,PM,FG, process Consumables.
Planning and co-ordination to ensure timely availability of all pre-requisites related to projects (RM, PM).
To co-ordinate with all cross functional teams to ensure project execution within stipulated timelines.
Technical support at critical stages of manufacturing during execution of scale up/engineering and submission batches of injectable and complex injectable projects at site.
Preparation & or review of scale up/engineering batch protocol and reports.
Preparation & or review of BMR and BPR and other reports.
Statistical analysis of CQA and historical analytical data.
Technically support at critical stages of manufacturing for execution of prospective process validation batches at site in terms preparation of Process validation and sampling protocol and compilation of process validation report.
Technically support at critical stages of manufacturing for post launch process validation exercise like batch size change, capacity utilization and other routine commercial batches (as per requirement).
Ensure adherence to cGMP’s, standard operating procedures, safety practices and manufacturing protocols. Ensure the safety through compliance with all company policies, procedures, safety rules, and regulations.
Ensuring that standard operating procedures are followed and prepared in accordance with all regulatory requirements and best practices.
Participate and/or contribute Continuous Improvement initiatives like reduction of cost of goods, manufacturing cycle times, and all forms of waste.
Participate in regulatory and internal audits and inspections. Draft response preparation to audit observations in a timely manner.
Train and develop a staff of professionals across all assigned functions.
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.