Tapan Kumar Panda

Worked as Head of Quality by Leading the Quality assurance and Quality control function in NatiVita, Belarus. The major tasks/ highlights in this role are:  Guiding the technology transfer, validation and QC team for successful technology transfer and execution of cytotoxic solid oral and Monoclonal antibodies injectable products during all phases of method transfer and product transfer and ensuring compliance to cGMP. Successfully Transferred 2 cytotoxic tablets, 1 cytotoxic capsule, and 3 lyophilized monoclonal antibodies injectable formulation.  Usage of single use system for Injectable manufacturing.  Finding out the Gaps in the existing system and updating them as per international standard.  Auditing the supplier of raw material and semi-finished goods ( Performed 5 audits as lead auditor in last 4 months)  Ensuring smooth functioning of QMS (change control, CAPA, deviation etc.).  Establishing new policy and procedures which are lacking or have not been established.  Establishing Quality standards in the organization to meet with requirements of EU GMP.  Training the validation team on risk based qualification of equipment (as per ASTM E2500), facility, process and computerized system.  Guiding the IT team in identifying the risk associated with data integrity in computerized system and mitigating the risk.  Guiding the team to perform risk assessment for various subjects like Data integrity, Cross contamination, risk assessment of excipients used in formulation, risk assessment for elemental impurities (ICH Q3D) etc.  Aligning the team goal with the company goal and organizing the team work accordingly to meet the timelines.

Heading the QA-Validation department and handling the following activities : - Handlig the regulatory audit such USFDA , EU GMP and other customer audit. - Handling of compliance of external audit. - Conducting internal Quality audits. -Handling of QMS documents -Training the people as per the training calendar. - Qualification of Oral solid and Oral liquid Equipment and Facility. - Qualification of Clean room utilities such as HVAC system, purified water system, compressed air system etc. - Qualification of Quality Control & microbiology Equipment - Validation of computerized systems per the requirements of 21 CFR Part 11. - Validation of SAP system ( All GMP modules PP,WM,QM, PM etc.) - Process validation for US , Europe and ROW market. - Packaging validation for the products. - Review of batch records and providing technical inputs. - Hold time study for product. - Cleaning validation oral solid and Oral liquid facility using ADE concept. - Risk assessment for the facility and systems.

During the tenure in Dr Reddys learned and played various roles in Validation department. Starting with the role of a technical trainee, moved on to the role of manager within 7 years due to the learning ability and achieving department milestones without any failure. During the tenure got exposure to various dosage form like Tablets, capsules, sachets, pellets, cytotoxic tablets and capsules, liquid and lyophilized injectable, Ointments. The major tasks handled are as below: 1. Successfully handled cleaning validation activities across Formulation units of Dr Reddys for all dosage forms (Solid, Semi-solid and Injectable) . Implemented PDE approach for calculation of cleaning validation acceptance limit as per the new EMA guideline. 2. Successfully handled the Qualification activities by participating and guiding the team members for the completion FTO 3 Facility Expansion Project and FTO-2 Facility Expansion Project. 3. Qualification of computerized systems available on process equipment in adherence to 21 CFR Part 11 requirements. 4. Preparation of Master Documents like Validation Master Plan and Master cleaning validation Plan and SOP’s. 5. Handled the Quality Management System for the following activities :  Evaluation of change control documents for assessment of validation activity.  Handling of documents like Deviation, Change control, Incident, CAPA and Investigations. Directly involved in preparation of these document.  Involved in Incident investigation, Root cause analysis and implementation of CAPA.  Actively participated in the Quality Risk Management Plan for the cross contamination in the multiproduct facility at FTO3 in Dr Reddys Lab 6. Handled all major and minor audits across 10 formulation units of Dr Reddys lab for Cleaning validation related activities and documents.