Deputy Manager

1 week ago

Delhi, Delhi, India Par Formulations Full time


Leads new product development/project planning and assessment (microbiology perspective), Global Microbiology Policies and Harmonization, new technology evaluation, QMS, education/training, and provide complex investigation support to QC Microbiology.

Leads the process for determining specifications and specification justifications for raw materials and drug products.
Mentors the development and validation of microbiological/biological methods and the evaluation of compendial changes/updatesActs as a liaison between the LTS-Microbiology and Quality Control groups for transfer of knowledge and technologyMentors the Method Validation team for Developing and validation experiments designed to provide support for process and formulation activities (e.g.

biological challenge, microbiological DS and DP methods)Prepares general method validation protocols, harmonized report templates, harmonized microbiological/biological test methods, and microbiological sections for regulatory submissions if requiredLeads new product development/project planning and assessment (microbiology perspective), Global Microbiology Policies and Harmonization, new technology evaluation, QMS, education/training, and provide complex investigation support to QC Microbiology.

Leads the process for determining specifications and specification justifications for raw materials and drug products.
Mentors the development and validation of microbiological/biological methods and the evaluation of compendial changes/updatesActs as a liaison between the LTS-Microbiology and Quality Control groups for transfer of knowledge and technologyMentors the Method Validation team for Developing and validation experiments designed to provide support for process and formulation activities (e.g. biological challenge, microbiological DS and DP methods)Prepares general method validation protocols, harmonized report templates, harmonized microbiological/biological test methods, and microbiological sections for regulatory submissions if required.

Evaluates, troubleshoots/improves existing microbiological/biological methods when necessaryIndependently performs scheduling and coordination of activities of assigned projectsOversees project status to ensure that project timelines are met and the team works in compliance with cGMP, GLPs and all other applicable requirements.

Presents proposed assessments and harmonized programs to LTS/QC teams for review and discussionWrites and reviews SOPs, test methods, general validation protocols and harmonized validation report templatesReviews laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test method, validation protocol, or validation report) for completeness and compliance, when necessary, in support of regulatory filings and commercial product maintenanceReviews and evaluates drug substance supplier's technical documents and provides recommendations of API vendor selectionIs alert to and detects abnormalities during performances of tests and reviewsAssist in complex laboratory investigationsLeads root cause identification of complex laboratory investigationsEvaluates questionable sample results, OOS, and aberrant results and recommends a course of actionWrites, edits, and reviews SOPs and laboratory investigationsIdentifies need for SOPs and writes or revises, as appropriatePerforms work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.

Works in compliance with cGMP/cGLP regulationsApprises management of the status of investigations and works with the Compliance group on determination of regulatory actions to be takenDocuments data generated in notebooks/worksheets/LIMS in compliance with SOPsTakes active role in auditing laboratory logbooks/documentation to ensure complianceEducation & ExperienceMaster's Degree in above disciplines with 10 years' relevant microbiological/biological lab experienceCommitment 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.

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