Post: Quality Specialist III
Job Description:
The primary responsibility of the Executive, QAS In-Take Team position is to process complaints, liaise with manufacturing sites, perform the daily distribution of complaints received via email/internet/voice mail message, and notifications to sites and send updates regarding critical/high-profile complaint events to QAS management. Additional responsibilities include reporting of metrics (monthly reports), daily troubleshooting of complaints, LMS and STUDIUM tasks, handling reconciliation activities, and conducting huddles.
- Assists QAS Intake team management in handling QAS Intake team activities:
- Serve as a Subject Matter Expert on all In-Take Team complaint processes and scenarios.
- Assist QAS employees to ensure compliance with Quality Assurance Services Standard Operating Procedures and Work Instructions.
- Collaborate with QAS Daily review team and/or closing team to discuss and calibrate on varying views on how records should be handled.
- Responsible for handling High-Profile complaints.
- Conduct a day-end review to ensure proper justification is provided for and documented in all High-Profile complaints.
- Participate and contribute to the continuous improvement activities of the QAS group:
- Participate in the continuous improvement of the QAS Group to drive operational excellence.
- Support audits and inspections of the QAS group.
- Provide data related to product complaints, volumes, Deviation reports as required.
- Identify automation and defect-proofing opportunities and highlight the same to QAS management via business cases, quantifiable data.
Candidate Profile:
- 1 to 4 years of experience with a Bachelor’s of Science Degree in a scientific field preferably, Pharmacy, Chemistry, Micro-Biology, Chemical Engineering.
Shift:
- Night Shift (6 PM to 3 AM)
- Hybrid Working (3 Days working from the office and 2 days working from home)
Additional Information:
- Experience: 1-4 yrs
- Qualification: B.Pharm, BSc
- Location: Bangalore
- Industry Type: Pharma/ Healthcare/ Clinical research
- Job ID: 54616
- End Date: 30th March 2024
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