About the role
Key Responsibilities 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.
- 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
Millions of jobs, with real people getting hired every day
Questions, answered
Click "Apply with JobAssist" – we tailor your resume and application to this role and submit it for your approval.
Yes. This role at Amneal Pharmaceuticals was screened before publishing – we confirmed the employer before listing it.
The employer didn't disclose a salary range for this listing. JobAssist shows pay whenever it's available.
This position can be done from anywhere, with no in-office requirement.
Yes – every application is tailored from your profile and this job's requirements, and you can review and edit before it's sent.