Assistant Manager, MSTG

Amneal Pharmaceuticals LLC

Hinoba-an

On-site

PHP 600,000 - 900,000

Full time

3 days ago

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Job summary

Amneal Pharmaceuticals LLC in the Philippines seeks a qualified professional to support investigations into market complaints and OOS/OOT for injectable manufacturing sites. You will coordinate with QC, QA, RA, and R&D to drive timely investigations and CAPA closure while maintaining metrics and action logs.

Responsibilities include reviewing investigation reports, data analysis with Six Sigma tools, and collaboration with site teams to implement process improvements and robust product quality.

Qualifications

Experience with injectable dosage forms and sterile unit operations.
Strong understanding of equipment operation.
Proactive approach toward problem solving.
Good documentation, coordination and communication skills.

Responsibilities

Support commercial troubleshooting/remediation and Market complaints for injectable manufacturing sites at Level 2.
Support timely investigation/execution and to resume commercial manufacturing to meet market/sales requirements.
Review site investigation report, Product/Method development report, and historical data trending using Six Sigma tools.
Communication with site for root cause and CAPA, and participation in CFT discussions with sites.
Close coordination with QC, manufacturing, QA, RA, and R&D to meet turnaround time (TAT).
Record and follow up on meeting actions, metrics and improvement initiatives.

Skills

Analytical and problem solving

Conflict management

Proactive support management

Equipment operation understanding

Education

Master in 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