Mumbai, Maharashtra, India
Posted: Dec 28, 2023
Full-time
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Skills Required
Pharmaceutical
expert
API
expert
Manufacturing
Proficient
Quality Control
Proficient
Communication Skills
Proficient
Negotiation Skills
Proficient
Regulatory Affairs
Proficient
Nice To Have skills
Job Description
The role requires active collaboration with Elanco Global HSE, Engineering, Procurement, RD, Supply Chain, Commercial and Quality covering a wide variety of manufacturing processes and project initiatives.


Functions, Duties, Tasks:

Key Objectives / Deliverables

  • Provide internal support across EEM India Bangladesh hub to ensure compliance with HSE regulations and standards.
  • Carry out HSE assessments at suppliers and CMO’s of the EEM hub and follow up on effective completion of remediation plans proposed by CMO’s and suppliers.
  • Conduct due diligence audits to support new projects and procurement initiatives.
  • Provide Elanco HSE product stewardship support for the Elanco technical transfer agenda for products managed by CMOs under the responsibility of EEM India Bangladesh Hub.
  • Provide leadership support between CMO’s and Elanco EEM supply chain for SDS and Dangerous Goods change controls that impact the supply chain.
  • Contribute to CM capability building in HSE related aspects
  • Provide on ad hoc HSE lead to support manufacturing process changes and technical transfers, either into or from contract manufacturers.
  • Provide HSE impact assessment for change controls, deviations, product launches, product rationalizations
  • Ensure HSE metrics are accurate for EEM and commercial HSE reporting
  • Ensure effective safety leadership, safety culture and performance in India and Bangladesh for Elanco commercial and IAC activities.


Accountabilities

  • Support of PSCI activities in India and remediation activities at India Bangladesh sites.
  • Proactively search for solutions with a strong technical foundation in HSE product stewardship aspects.
  • Create innovative, effective and streamlined solutions and partnerships for integrating HSE requirements into Elanco existing business process supporting API and drug product site HSE risk management approaches including working in full partnership with the EEM international, EEM China, EEM North America and EEM API hubs.
  • Lead engineering/process improvements as identified as necessary for significant risk reduction while ensuring product supply (including resource and budget management).
  • Determine trends and highlight to management when changes need to be made to improve HSE standards.
  • Perform root cause analysis for significant HSE events and critical audit observations and ensure timely implementation of corrective actions.
  • Participate in the global HSE EEM representative team meetings for replication of improvement activities.
  • Provide technical leadership/consulting for process safety management, product safety information (PSI), Combustible dust, and Fire Safety to the entire EEM network.


Minimum Qualification:

  • Master degree and at least 15 years’ experience in Engineering, Manufacturing and HSE – with a proven track record of performing audits or technical assessment of external partners.
  • Strong PSM (Process Safety Management) expertise
  • Good knowledge of HSE management systems and HSE product stewardship areas, metrics reporting, Global Contract Manufacturing and Quality Standards and processes.
  • Demonstrate understanding of HSE local regulatory requirements
  • Strong interpersonal skills with strong influence track record with external suppliers.
  • Excellent communication and negotiation skills.
  • Ability to handle multiple priorities and deal with ambiguity.
  • Demonstrate continuous improvement mindset.
  • Ability to work in global matrix organization and in multicultural and virtual teams.
  • Language requirements: English, Hindi.

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Company/Employer
Elanco
Additional Info
Min. Experience
-
Job Location
Flexible
Job Type
Full-time
Job Seniority Level
-
Job Duration
Any
Language(s)
English,Hindi
Est. Budget/Pay Rate
To be discussed
Est. hrs
-
Optimal Job Start
Flexible
Job Industry
-
Job Function
-
Applicant Countries
Bangladesh,India,
Job Ref
J23CA0D62CB38