Gland Pharma | Walk-in interview for IPQA activities| 24th April 2019 | Visakhapatnam

We have urgent requirement for 
1. Day to Day Monitoring of IPQA activities (Sterile / non Sterile) and 
2. Analytical QA in Microbiology - Gland Pharma Limited. Please have a glimpse on the
Job description;

IPQA Activities : Experience (1-2 years) 


1. Check for adherence to standard operating procedures in all departments.
2. To check all the departments, which contribute to production of APIs for any deviation from GMP. 
3. To review the product manufacturing records (BPCRs, MPCRs, Log books etc.), testing records and quality of release batches before the dispatch of products.
4. Monitoring and coordinating the raw material dispensing, finished product packing and labeling and preparation of product labels activities.
5. To ensure all the departments documents are written in accordance with the good documentation practices requirements. 
6. Archiving of documents and maintenance of record rooms.
7. To indent and maintain the required stationary for QA operations.
8. To ensure preventive maintenance, calibrations of equipment's and instruments are completed in all API blocks as per schedule.
9. Ensure the implementation of Good Laboratory practices and good manufacturing practices. 
10. Support during process validations and equipment qualifications.
11. Responsible for ensuring the Validation & Calibration activities. 
12. Preparation of the annual quality review reports of products
13. Responsibility to initiate change controls and deviations as applicable. Ensure the implementation of changes and corrective and preventive actions.
14. Issuance of formats, log books and documents to user departments. 
15. To undertake any other job as assigned by the Head of Department QA.


Analytical QA (Microbiology) : Experience (5-6 years) 
• 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.

Job Specification:
Should follow SOP.
Communication skills.

If you are interested please walk-in on 24.04.19 (Wednesday) between 9.30 AM to 11.00 AM.