Job Overview
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Date PostedJune 29, 2023
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Location (State / UT)
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Expiration dateAugust 4, 2024
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Experience1 Year, 6 Years
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GenderAny
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Desired QualificationBachelor Degree, Master’s Degree
Job Description
Roles and Responsibilities
Quality management system
- Coordinate with the cross-functional department for execution of training planners and maintain training records for same.
- To master, issue, and retrieve SOPs/BMR/BPR/QC dockets and other documents in line with the laid down procedure.
- To maintain vendor-related documents and conduct vendor audits.
- To investigate and prepare a Market Complaint investigation report.
- To take follow up and communicate with customers/vendors regarding Complaints.
- To handle Change control/Deviations/Incidents/NCR/CAPA.
- Review of quality technical agreements.
Process Validation
- To prepare process validation and Bulk hold Time Study protocol and report.
- Execution and compilation of Process Validation and Bulk hold time study as per protocol.
- Preparation of Annual Product Quality Review
- Responsible for maintaining and tracking the Process validation and Product bulk hold time study
- Responsible for initiating/checking/handling Quality management system documents i.e. Change Control / Deviation / Incident / OOS/ OOT / CAPA.
Desired Candidate Profile
- Candidate must have experience in Injectable plant
- Good Verbal & Written skill
- Proficient in Ms office/Excel & Word
Qualification: B.Pharma, M.Pharma, MS/M.Sc (Science) in Organic Chemistry