M&S Services, Specialist Quality Services - Product complaints, KL Hub
at Sanofi US
Petaling Jaya, Selangor, Malaysia -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 08 Nov, 2024 | Not Specified | 09 Aug, 2024 | 3 year(s) or above | Biologics,Analytical Skills,Code,Pharmaceutical Industry,Federal Regulations,Information Technology | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
EXPERIENCE:
- 3+ years of related experience in the pharmaceutical industry.
- Knowledge of cGMPs, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools.
- Should be knowledgeable in Quality functions of pharmaceutical industry.
- Experience of working on manufacturing sites is an added advantage.
- Proficient in problem-solving, attention to detail, and good organizational skills.
- Work in a team-oriented, flexible, and proactive manner.
- Analytical skills and ability to multitask in a stressful environment.
- Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology.
Responsibilities:
- Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure, ensuring compliance with internal procedures and regulatory requirements.
- Evaluate complaints for severity and risk, ensuring timely review and processing.
- Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites.
- Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations.
- Focus on operational tasks within the compliant handling process.
- Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections.
- Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments.
- Identify and implement continuous improvement opportunities in complaint management.
- Provide regulatory interpretation and guidance to internal teams and corporate partners.
- Manage and oversee the training within the team.
- Perform quality checks on activities, prepare reports, and maintain inspection readiness.
REQUIREMENT SUMMARY
Min:3.0Max:8.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
Petaling Jaya, Malaysia