Job Description

Key Responsibilities:

• To Support commercial troubleshooting/remediation/Market complaints for injectable manufacturing sites at Level 2.
• To support for timely investigation/execution and to resume commercial manufacturing to meet market/sales requirements.
• To support review and approval of investigation protocol and report.
• To provide technical support at any stage of commercial manufacturing as required by site (QC, QA or Production).
• Prioritization of refer issues from site and conduction meeting for the same. Maintain the investigation tracker and update the leadership weekly.
• To collect data on intimation of failure OOS/OOT/market complaint by site.
• To review site investigation report, Product/Method development report, historical data trending by applying six sigma tools i.e statistical analysis.
• Perform exploratory literature search and review for support assigned investigation.
• Planning and execution of investigational hypothesis and generation of data as a part of investigation.
• Communication with site for root cause and suitable CAPA and participation with CFT discussion with sites.
• Close co-ordination with QC, manufacturing, QA, RA, R&D to meet TAT.
• To provide suggestions to manufacturing site for improvement in process to improve product robustness.
• Record and follow up on meeting actions, metrics and improvement initiatives.
• Preference will be given to candidate who have following experience and skills:
• Exposure/Experience to injectable dosage form with excellent command on sterile unit operation.
• Strong understanding of equipment operation.
• Statistical data evaluation.
• Proactive approach toward Problem solving.
• Good documentation, coordination and communication skills.

Education : Master in Pharmacy

Relevant experience in MSTG/Technology Transfer departments.

2 years of Minimum experience is required for Internal Job posting