Assistant Manager, MSTG

Amneal Pharmaceuticals; Gujarat; On-site; INR 600,000 - 800,000; Full time

Job summary

Amneal Pharmaceuticals in Gujarat, India seeks a Master of Pharmacy holder to support investigation, troubleshooting and technology transfer related to injectable manufacturing. You will coordinate with QC, QA, RA, and Production teams to drive CAPA and ensure timely resumption of production.

The role emphasizes data-driven investigations, root-cause analysis, and cross-functional collaboration to sustain product quality and market supply.

Qualifications

• Master of Pharmacy required.
• Minimum 2 years of MSTG/Technology Transfer experience.
• Internal job posting requires relevant experience.

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.

Skills

Injectable dosage form

Sterile unit operation

Statistical data analysis

Problem solving

Documentation

Equipment operation

Education

Master of 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, 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.

Preferences

• 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.

Qualifications

Education : Master in Pharmacy

Relevant experience in MSTG/Technology Transfer departments.

2 years of Minimum experience is required for Internal Job posting