- Day to Day Monitoring of IPQA activities (Sterile / non Sterile) and
- Analytical QA in Microbiology - Gland Pharma Limited. Please have a glimpse on the
- Check for adherence to standard operating procedures in all departments.
- To check all the departments, which contribute to production of APIs for any deviation from GMP.
- To review the product manufacturing records (BPCRs, MPCRs, Log books etc.), testing records and quality of release batches before the dispatch of products.
- Monitoring and coordinating the raw material dispensing, finished product packing and labeling and preparation of product labels activities.
- To ensure all the departments documents are written in accordance with the good documentation practices requirements.
- Archiving of documents and maintenance of record rooms.
- To indent and maintain the required stationary for QA operations.
- To ensure preventive maintenance, calibrations of equipment's and instruments are completed in all API blocks as per schedule.
- Ensure the implementation of Good Laboratory practices and good manufacturing practices.
- Support during process validations and equipment qualifications.
- Responsible for ensuring the Validation & Calibration activities.
- Preparation of the annual quality review reports of products
- Responsibility to initiate change controls and deviations as applicable. Ensure the implementation of changes and corrective and preventive actions.
- Issuance of formats, log books and documents to user departments.
- To undertake any other job as assigned by the Head of Department QA.
- Check for adherence to standard operating procedures in all departments.
- To check all the departments, which contribute to production of APIs for any deviation from GMP.
- To review the product manufacturing records, testing records, release batches quality and yield before dispatch of products.
- To monitor the manufacturing activities in the shifts like online process checking, online documentation.
- Monitoring and coordinating the raw material dispensing activities.
- To co-ordinate for in-process sampling and to monitor the quality of in- process samples during manufacturing of APIs.
- Archiving of documents and maintenance of record rooms.
- To indent and maintain the required stationary for QA operations.
- To review and maintain vendor documents and co-ordinate Head-QA during vendor qualification
- To check the all gauges in the API block and validation of equipments.
- Monitor the preventive maintenance program in all API blocks.
- Implement a document system to develop, maintain, distribute and control all manufacturing records, forms, procedures and policies related to API manufacturing.
- Ensure the implementation of Good manufacturing practices.
- Ensure and provide GMP Training as per schedule.
- Responsible for ensuring the Validation & Calibration activities.
- Guide during validation & Qualification protocols preparation, and monitor the implementation as per the documented procedures
- Preparation of the annual quality review reports of products
- Preparation and Review of SOPs.
- Responsible for ensuring the deviations and OOS are investigated and necessary corrective and preventive actions are implemented
- Responsibility of Sterile operations
- Responsibility to handle the change controls and to ensure the implementation of changes
- Preparation of Site master file and Validation master plan
- Preparation and Review of the quality risk assessment.
- Responsible for handling of customer complaints.
- Co-ordinate and provide documents pertaining DMF filings.
- Co-ordinate the handling of returned goods
- Responsible for ensuring the deviations and OOS are investigation and necessary corrective and preventive actions are implemented
- To undertake any other job as assigned by the Head of Department QA.
We have urgent requirement for
Job description;
IPQA Activities : Experience (1-2 years)
Analytical QA (Microbiology) : Experience (5-6 years)
Job Specification:
Should follow SOP.
Communication skills.
If you are interested please walk-in on 15.05.19 and 16.05.19 (Wednesday & Thursday) between 9.30 AM to 11.00 AM.
We have urgent requirement for
IPQA Activities : Experience (1-2 years)
Analytical QA (Microbiology) : Experience (5-6 years)
Job Specification:
Should follow SOP.
Communication skills.
If you are interested please walk-in on 15.05.19 and 16.05.19 (Wednesday & Thursday) between 9.30 AM to 11.00 AM.
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