Job Overview
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Date PostedJanuary 15, 2023
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Location (State / UT)
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Expiration date--
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Experience10 Years
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GenderAny
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Desired QualificationBachelor Degree, Master’s Degree
Job Description
Role & Responsibilities:
- Development of electronic BR to achieve productivity, quality, and compliance.
- Improvement of electronic batch record (EBR) by taking initiatives and detecting opportunities from the shop floor.
- To assess new site requirements towards the conversion of paper documents to electronic format and to work closely with AMPS and SAP project team to implement same.
- Working with the team for AMPS, SAP, Material Label Management, and related project enhancements.
- Communicate with support teams across the globe and build solutions.
- Ensuring on-time closure of all open SAP/ AMPS/MLM-related batch execution issues.
- Responsible to ensure the timely closure of BT tickets related to electronic batch records to meet batch release plan.
- Ensuring completion of the project to meet the business timeline.
- Deploy manpower optimally and conduct /ensure the on-Job training for newly joined employees.
- Supervising and motivating team members.
- Reviewing the performance of team members periodically.
- To assess any new hire requirement in advance and to ensure the availability of resources in coordination with the HR team.
- Ensuring new hires’ training completion in synchronization with the training department.
- To bring innovative ideas towards simplification of the process.
- Ensuring compliance with the workplace safety program.
Qualifications
Must-Have
- Graduate or Postgraduate in Pharmaceutical Science Discipline/Engineering.
- Minimum 10+ years of experience in manufacturing pharmaceutical dosage forms, in manufacturing operations.
- Technical knowledge of Production injectable manufacturing (end-to-end operations), Production Planning, and Quality management system.
- Experience and hand with electronic batch record design along with any associated software (i.e., AMPS, SAP, etc.) working exposure.
- Good knowledge of regulatory requirements on electronic systems.
- Experience in internal and external audits and audit responses.
- Strong interpersonal skills
- Analytical thinking to grasp complex technical issues and provide feasible solutions to users.
- Effective communication skills are required, both written and verbal.
- Ability to communicate effectively with all cross-functional teams (CFTs) within the organization.
- Must be comfortable working both independently and collaboratively.
Nice-to-Have
- Master’s degree
- Previous experience with SAP, LIMS supporting systems, New Projects handling