Assistant Manager, MSTG

RXinsider LTD.; Gujarat; On-site; INR 900,000 - 1,500,000; Full time

Job summary

RXinsider LTD. in India (Gujarat) is seeking a Biomedical/Pharmaceutical professional to support Level 2 troubleshooting and investigations for injectable manufacturing sites. The role focuses on timely investigations, CAPA, and collaboration with QC, QA, and Production teams.

The candidate will review protocols, reports, and historical data, and contribute to process improvements to ensure robust manufacturing and on-time market supply.

Qualifications

• Experience with injectable dosage forms and sterile processing.
• Strong documentation and data recording abilities.
• Familiarity with six sigma or statistical tools is a plus.
• Ability to coordinate across QC, QA, Manufacturing teams.

Responsibilities

• Support troubleshooting/remediation and market complaints at Level 2 for injectable sites.
• Assist investigations to resume commercial manufacturing to meet market/sales requirements.
• Review and approve investigation protocols and reports.
• Provide technical support across sites (QC, QA, Production).
• Maintain investigation tracker and update leadership weekly.
• Collect data on OOS/OOT/market complaints and escalation.
• Review investigation reports, development data, and trend historical data.
• Conduct literature reviews to support investigations.

Skills

Injectable dosage form experience

Sterile unit operation

Equipment operation

Statistical data evaluation

Problem solving

Documentation and communication

Education

Master in Pharmacy

Experience in MSTG/Technology Transfer

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