Devaraj Biswal Email & Phone Number

Hyderabad, In

Hyderabad, Telangana, India

● Qualification of SBPs (CMO/Testing facility) & monitor their day-to-day activities. ● Vendor qualification of raw material & packaging material. ● Ensure the product is manufactured as per cGMP and the agreed process. ● Handling the site's internal audit program & customer audit. ● Support to the manufacturing site for regulatory audit and customer audit. ● Actively participates in developing stakeholders enabling the GMP compliance requirements. ● Support for the development of the product from the inception to the filling stage. ● Review & approval of MDR, PDR, MVR, and all development related documents of the product. ● Review & approval of MFR, Master Batch Record, Protocol, Report, Specification, and STP. ● Review & approval of executed batch records of Clinical trial/ Bio/ Exhibit Batches. ● Responsible for technology transfer, batch release, and dispatch to the customer. ● Provide support to ANDA / NDA filling and respond to customers' queries. ● Handling of QMS elements (CC, CAPA, Incident, complaints & investigations, etc.). ● Review of SOPs, Quality system documents like SMF, Quality Manual, Quality Agreements, Quality Risk Management reports, and Quality Trend Reports, etc. ● Presenting QMS & quality issues to Sr. management through QRM presentation.

Hyderabad, Telangana, India

● Prepare and review quality system-related SOPs and documents like SMF, quality manual etc. ● Review all cross-functional department SOPs for their appropriateness. ● Managing document archival and retrieval procedures. ● Handling training programs and impart training. ● Review & approve qualification protocol and report for the equipment and instruments. ● Responsible for change controls, deviations & CAPA management. ● Responsible for supplier management. ● Handling of process feasibility trial/process improvement trial executed at customer site. ● Review the investigation reports, and decide on further action plans. ● Approval of the trial plan for the execution of the trial for troubleshooting. ● Review of BPRR or LNB of trial for the correctness of process and data. ● Ensure to implement the trial outcome and prepare the closure report.

Hyderabad, Telangana, India

● Handling of Failure Investigation reported from PNC/OOS/OOT/Product Complaint. ● Handling of PNC (Process Non-Conformance)/ MNC (Material Non-Conformance). ● Handling exceptions and performing their impact assessment. ● Handling Quality Risk Management for the site. ● Preparation of response for regulatory and customer audit findings. ● Act as vendor coordinator for the site and responsible for handling material discrepancies. ● Responsible to reply to customer quarry for allergen information. ● Handling of Near Miss Events. ● Tracking of recommended CAPA and follow-up to their implementation. ● Trending of PNC, MNC, Exception, Failure Investigation, and CAPA and drawing their conclusion. ● Handling of process feasibility trial/process improvement trial. ● Review of the trial plan and implement the trial outcome for process robustness.

Ahmedabad, Gujarat, India

● Prepare the APQR report as per their schedule. ● Verify the implementation of recommendations identified in the APQR report. ● Prepare Continued Process Verification Report (3rd Phase Validation). ● Discussion of the process voice and OOT results with QC & Manufacturing dept. ● Management of batch record issuance and their controls. ● Management of Method, Specification, and SOP distribution and control. ● Handling change controls and following up for their closure. ● Revision of departmental SOP as per their requirement.

Ahmedabad, Gujarat, India

● Prepare the PQR schedule and prepare its report. ● Tracking the implementation of the PQR recommendation. ● Monitoring of retained samples and recording the observations in the register. ● CAPA Tracking up to their implementation and closure.

● Perform day-to-day IPQA activities & ensure compliance with cGMP. ● Online review of GMP documents like balance verification records, temperature, % RH records & differential area air pressure records. ● Checking of in-process parameters during manufacturing & packaging activities. ● Sampling of intermediate & finished product samples, hold time samples, validation samples, stability samples, control samples & Q.P. samples. ● Online review of the filled batch record of all stages of tablets, capsules, suppositories, DPI & ointment dosage forms and make them release stage-wise. ● Collection of data for APQR preparation. ● Assisting in the investigation arising from deviation & batch failure.

Master'S Degree, Pharmaceutics And Drug Design

Bachelor Of Pharmacy - Bpharm, Pharmacy, First