Piramal Pharma Solutions (PPS)
Designation : Deputy Manager
Reporting To : ,
Function : QC
Functional Area : Quality Control
Job Role Summary : Labware LIMS Management, QC Documents Review, Laboratory Work Allocation, QMS activites
Job Profile :
- Responsible for Labware LIMS Masters and Routine execution and trouble shooting, Interface issues resolution
- To allocate work of chemical and Instrumentation area and ensure timely completion of work. Ensure allocated work is in line with Analyst Qualification reports.
- Analyticla data Review, Investigation and Change controls and QMS activities.1. Responsible to maintain the laboratory as per good laboratory practices, good documentation practices, 21 CFR guidance and meets cGMP Requirement.
- Preparation and checked by of the COA’s for RM,PM,FP,API IMT and working standard etc..
- Prepare Stability Schedule, Stability protocol and Report, Validation/ Qualification, Trending reports.
- Review Qualification, Validation, Calibration data, Procedures, Protocol, Audit Trail on timely manner.
- Review QC Logs, Incidences, Reports and ensure document archival after released of samples.
- Ensure Control sample inspection and Leftover sample disposal after analysis.
- Ensure Instrument calibration and AMC done as per the schedule.
- Prepared and Revised SOPs, Specification and Procedure in line with Regulatory requirement.
- Review of packing materials, raw materials, stability samples, in process and finished products data.
- Overall responsible for Internal & External vendor follow ups and completions within the timelines.
- Responsible to procure and maintain the minimum stock for working standards, reference standards, impurity standards, chemicals, reagents, glass wares and solvents required for analysis and ordering as and when required.
Job Requirements :
- QC Experience in Regulated Pharma
- Experience handling LIMS, cGMP documents in QC, Incident Investigation
Work / Job Experience : 5-10 Years
Type of Experience : Pharma QC experience
Academic Qualifications :
- Graduates/ Post Graduates Science / Pharmacy
