Assistant Manager MSTG

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

Job summary

Amneal Pharmaceuticals in India is seeking a specialized professional to support investigative and remediation activities for injectable manufacturing sites. The role focuses on timely investigations, data trending with Six Sigma tools, and collaboration across QC, QA, and Production to meet market requirements.

The candidate should have Master in Pharmacy with MSTG/Technology Transfer experience and a proactive, well-documented approach.

Qualifications

• Education: Master in Pharmacy.
• Relevant experience in MSTG/Technology Transfer departments.
• 2 years of Minimum experience is required for Internal Job posting.

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.
• 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.

Skills

Sterile injectables

Equipment operation

Statistical analysis

Problem solving

Documentation & coordination

Education

Master of Pharmacy

Experience MSTG/Technology Transfer

Internal job posting experience

Tools

Six Sigma

Job description

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.

Qualifications

Education : Master in Pharmacy

Relevant experience in MSTG/Technology Transfer departments.

2 years of Minimum experience is required for Internal Job posting

Requirements: