Assistant Manager, MSTG

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad is seeking a qualified professional to support investigations and troubleshooting for injectable manufacturing, ensuring timely investigations and resumption of production to meet market demand.

The role involves reviewing investigation protocols, providing technical support across QC, QA and Production, and coordinating with site teams to implement CAPAs. Prior experience in MSTG/Technology Transfer and statistical data evaluation is preferred.

Qualifications

• Experience with MSTG/Technology Transfer preferred.
• Exposure to injectable products and sterile processing.
• Strong documentation and data analysis skills.

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, RD 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.

Skills

Injectable dosage form experience

Sterile unit operation

Statistical data evaluation

Problem solving

Documentation and coordination

Education

Master in Pharmacy

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, RD 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