Assistant Manager, MSTG

Amneal India

Gujarat

On-site

INR 600,000 - 900,000

Full time

8 days ago

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Job summary

Amneal India is seeking an internal candidate for a Pharmacy Investigator role in Gujarat. The role involves supporting troubleshooting for injectable manufacturing, ensuring timely investigations, and resuming production to meet market demand.

The incumbent will review investigation protocols, provide technical support across QC/QA/Production, and coordinate with multiple functions to meet tight timelines. A Master of Pharmacy and 2+ years of relevant experience are preferred.

Qualifications

Master of Pharmacy degree required.
2 years minimum experience for internal job posting.
Strong analytical and problem-solving skills.
Good documentation and communication skills.

Responsibilities

Support troubleshooting/remediation for injectable manufacturing sites at Level 2.
Ensure timely investigations and to resume commercial manufacturing to meet market demand.
Review and approve investigation protocols and reports.
Provide technical support across QC, QA or Production as required by site.
Prioritize site issues and maintain the investigation tracker; update leadership weekly.
Collect data on OOS/OOT/market complaints from site.
Review investigation reports and historical data using six sigma tools.
Perform literature searches to support investigations.
Plan and execute investigational hypotheses and data generation.
Communicate with sites for root cause and CAPA; participate in CFT discussions.
Coordinate with QC, Manufacturing, QA, RA, R&D to meet turnaround times.
Suggest process improvements to enhance product robustness.
Record and follow up on meeting actions and metrics.

Skills

Analytical thinking

Problem solving

Conflict management

Proactive support management

Education

Master of Pharmacy

Job description

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.
Proactive approach toward Problem solving.
Good documentation, coordination and communication skills.

Qualifications

Education : Master in Pharmacy

2 years of Minimum experience is required for Internal Job posting

Required Skills