Praveen Kumar

Having knowledge in manufacturing and packing Lifecycle and through understanding the business logic in all process involved. 10 years of total QA experience in Pharmaceutical Industry (Tablets and Capsules). Experience in preparation of URS, DQ IQ, OQ and PQ documentation a part of execution. Hands on experience on application SAP for batch release, sample deduction.

• Blood Group: O+
• Date of Birth: 17/02/1991
• Nationality: Indian
• Marital Status: Married

• Exposure with IPQA activities of Pharmaceuticals.
• LINE CLERANCE: Involving in the Line clearance activity at different stages like manufacturing, packing, and warehouse areas.
• INPROCESS CHECKS: Performing in Process Checks during Compression Encapsulation, and packaging areas.
• SAMPLINFG ACTIVITY: Performing Sampling activities at different stages like Granulation, Core, Coating and packing stages, Samples collected as per the manufacturing documents/Protocols, submitting all samples to QC for analysis within timeline.
• Expertise in Process Validation and collecting samples
• Expertise in cleaning (swab) Validation and collecting samples
• Performing Hold study sampling and submitting the samples to QC for analysis within time.
• Responsible in reserve sample collection Storage, and disposal of reserve samples for all the products manufactured in the firm.
• AQL ACTIVITY: Performing AQL activity at different stages like core, coated and encapsulation stages, pool sample collection and sample submission.
• Preparation of yearly Acceptable Quality Levels trends.
• BATCH DOCUMENT REVIEW: Review of executed Batch documents and Validation protocols.
• Review of executed logbooks at different stages like manufacturing, packing and Warehouse areas.
• ENSURING THE COMPLIANCE OF IPQA INSTRUMENTS: Responsible for ensuring of instruments like disintegration apparatus, friabilator, balance, Vernier callipers and hardness tester cleanliness and Calibration of IPQA instruments.
• Handling of SAP transactions for sampling and batch release.
• Preparation and execution of IQ, OQ and PQ documents for new equipment and utilities.
• Preparation, Execution and Review of Validation reports with respective to the process validation and cleaning validation.
• TRAINING MANAGEMENT: Coordinating and providing training for new employees and as well as existing employees for Quality Assurance team.
• To prepare the training schedule to all personal in Quality assurance team.
• Preparing JDs. Ensuring annual trainings training to department team members.
• To maintain the executed training documents as per the requirement.
• APQR: To perform annual product review for Apotex marketed products.
• Scheduling of product Quality review.
• To prepare, review & upload the product Quality review as per schedule.
• To perform control and capability analysis (CP & CPK) by using Minitab software for in Process Parameters and finished products analytical test results to evaluate the process robustness and for any Improvements and recommendations with respect to the process and testing.
• To create the observation records (Action Items) of Annual product quality review in QMS Track wise.
• QMS: Initiation, Assessment and verification and closure of change control in QMS Track wise and task extension.
• Initiation Assessment, and verification, tracking and closure of CAPA.
• Follow up with CFT for in time closure of given tasks and its adequacy and compliance.
• Audit Experience: USFDA, TGA, Health Canada, MHRA and others.
• Applications handled: Track Wise- For QMS -Incidents and change controls management.
• Computer skills- Proficient with the use of Microsoft Windows, internet, MS Office.
• SAP-For Products and Incidents management.

P. Penchalaiah

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• Kannada

• Reading news
• Watching TV
• Listening to music

I hereby declare that all the above furnished information and particulars are true to the best of my Knowledge.