Date & Time: 1st August, 9 AM onwards
Venue:
Granules India Limited,
Plot No 15A/1, Phase - III,
IDA, Jeedimetla,
Near Bus Depot,
Hyderabad -500055
Department: Quality Control
Position: Asst. Manager
Experience: 7 – 10 years
Job Location: Hyderabad
Job Description:
- Monitoring of cGLP followed by laboratory personnel during
routine operations to ensure adherence to procedure.
- Ensuring training of analysts in Laboratory techniques, Quality Control procedures and principles of cGLP / cGMP /General analytical methods instrumentation etc.
- Implementation QMS
- Qualification of Laboratory Instruments (IQ/OQ/PQ)
- Planning of day to day Laboratory activities
- Maintain Real time documentation and Laboratory safety around the clock
- Review of analytical documents followed as per cGMP and Quality Policies.
- Preparation and Responsible to peer-review of Stability Protocols, compile the stability data.
- Coordinating with Regulatory Affairs and fulfilling their requirements with respect to filling of new drug products and annual updating.
- Handling of customer complaints
- Checking the audit trails and analytical reports.
- Responsible for GLP compliance in the QC Department
- Preparation and review of Method transfer/Validation protocols
- Review of Instrument Calibration data
- Handling of Incidents, OOS, Change controls, OOT and all other cGMP record.
- Implementation of CAPAs
- Monitoring implementation of changes as per change control.
- Stability Management
- Preparation and review of specification and test procedures (STPs), General test procedures (GTPs) and cleaning methods.
- Preparation and review of Standard operating procedures (SOPs) and Validation Protocols.
- Review of Analytical Raw data sheets With respect to STPs, GTPs and SOPs.
- Preparation of Certificate of Analysis (COA) for Finished Products, and for Raw materials and intermediates.
- Review of BPCRs
- Preparation and review of Lab Metrics.
- Conducting the analyst qualifications periodically for the all the analysts in QC as per the schedule.
- Timely support to the regulatory activities in view of Revision of specifications and Test Methods
- Conducting the functional trainings and on job trainings to the employees in QC as per the schedule with evaluation.
- Responsible for compliance of Customer and regulatory Audits
- Ensuring training of analysts in Laboratory techniques, Quality Control procedures and principles of cGLP / cGMP /General analytical methods instrumentation etc.
- Implementation QMS
- Qualification of Laboratory Instruments (IQ/OQ/PQ)
- Planning of day to day Laboratory activities
- Maintain Real time documentation and Laboratory safety around the clock
- Review of analytical documents followed as per cGMP and Quality Policies.
- Preparation and Responsible to peer-review of Stability Protocols, compile the stability data.
- Coordinating with Regulatory Affairs and fulfilling their requirements with respect to filling of new drug products and annual updating.
- Handling of customer complaints
- Checking the audit trails and analytical reports.
- Responsible for GLP compliance in the QC Department
- Preparation and review of Method transfer/Validation protocols
- Review of Instrument Calibration data
- Handling of Incidents, OOS, Change controls, OOT and all other cGMP record.
- Implementation of CAPAs
- Monitoring implementation of changes as per change control.
- Stability Management
- Preparation and review of specification and test procedures (STPs), General test procedures (GTPs) and cleaning methods.
- Preparation and review of Standard operating procedures (SOPs) and Validation Protocols.
- Review of Analytical Raw data sheets With respect to STPs, GTPs and SOPs.
- Preparation of Certificate of Analysis (COA) for Finished Products, and for Raw materials and intermediates.
- Review of BPCRs
- Preparation and review of Lab Metrics.
- Conducting the analyst qualifications periodically for the all the analysts in QC as per the schedule.
- Timely support to the regulatory activities in view of Revision of specifications and Test Methods
- Conducting the functional trainings and on job trainings to the employees in QC as per the schedule with evaluation.
- Responsible for compliance of Customer and regulatory Audits
*** Thank you for Visit ***
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