Hospira is the world’s leading provider of injectable drugs and infusion technologies Through their broad, integrated portfolio, they are uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing healthcare costs.
Position : Sr. Executive – QC Remediation – Analyst
No of openings : 10
Experience : 8-10 years
Location : Aurangabad
Desired Profile : Bachelor Degree in a Chemistry or related field with at least 5 years related experience in pharmaceutical laboratory. or Master’s degree (M.S.) with at least 3 year laboratory experience
Job Description :
- Test Method Validation Remediation across the QC Labs
- Executing the TMV remediation activities across all 4 chemistry labs (Central, NPNC, Penicillin, and Penem)
- Manage and execute project activities within the established timelines.
- Resolves complex analytical issues through analytical thinking.
- Provide feedback and technical/ scientific support on any project deliverable, i.e. remediation strategy, plan reports, etc.
- Validating analytical methodologies following ICH guidance
- Oversee improvements to QC analytical methods, operational policies, plans and procedures
- Assist with the development of a remediation plan for newly created events while continuing to work closely with the assigned investigator throughout the investigation to ensure appropriate root cause and CAPAs are determined.
- Clearly interpret problems, make scientific judgment based on outcome of the obtained data and take appropriate actions to resolve the issues.
- Writing/ reviewing protocols, reports, SOPs, specifications & test procedures.
- Review and amend test methods and instrumentation SOPs as needed
- Establish robust Quality Control management and testing processes
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