Highlights:

Skills:Quality assurance, Qualification, Process validation, Project management, Process validation, Audit, USFDA, Equipment qualification, Utility qualification, Isolator, IQ OQ PQ FAT SAT VMP SMF, Quality Engineer, Quality Engineer, Quality Engineer, Quality Engineer

Assistant manager 08/2017 - current
Cadila Healthcare Limited Alidac Pharma, Ahmedabad, Gujarat India
Industry: Pharmaceutical
Group leader - Validation and Qualification department in Oncology Injectable Pharmaceutical Industry
Planning and tracking of documents requirements for new greenfield project equipment and review of qualification and CSV documents of vendor like URS, DQ, FS, DDS, IRA, FRS, URS tracebility matrix, SIA, CCA, PM matrix etc. Participate with project team on designing of new equipement/new system considering regulatory aspects, review of test requirements for FAT, SAT and perform FAT of the designed equipment. Preparation and review of risk based qualification and validation protocols, qualification SOP in documentum software as per regulatory recommandation. Planning and execution of periodic re-qualification of various equipement like Autoclave, Tunnel, Washing machine, HVAC, Smoke study, manufacturing skid etc. Participate in execution of Computer system validation (CSV) as per GAMP 5. Participate in gap assessment activity for process/system/equipement qualification in the facility and harmonise the approch for the gap identified to achieve management quality goal. SME of qualification and validation activity and face the internal and external audits and provide the compliance to audit observations. Participate in internal self inspection as a self inspector. Raise & Support the timely closure of Change Control, Deviations and CAPA related to validation and qualification in Trackwise software. Review of calibration, material certificates and utility qualification related certificates (Orbital welding, Boroscopy, Radiography etc.). To provide cGMP and validation related training and provide idea for smooth activity in the routine activity. To asses the global CAPA of qualification activity to the site and provide response to CQA. Audit Exposure : 3 USFDA (1st Runner during 3 USFDA audits). FAT Exposure : 1. FAT of Vial washing, tunnel, external washing and tray loader at IMA life, Florence, Italy. 2. FAT of integrated line (Vial washing, tunnel, filling and stoppering machine, Sealing machine, Loading and unloading unit for lyophilizer, Isolator, HVAC, external vial wash and tray loader at IMA Life, Bologna, Italy.--
Jr. Executive QA 04/2016 - 08/2017
Otsuka Pharmaceutical India Pvt. Ltd, Ahmedabad, Gujarat India
Industry: Pharmaceutical
Group leader for project as a quality assurance engineer
Execution (IQ, OQ and PQ) of New DRO Plant, WFI Plant, SPRO Plant, Autoclave, Sterilizer, Filling machine (Rommelag), AHUs, Manufacturing lines, Online APC, Online TOC, Chiller system, Air Compressor, Packing belt qualification, Parent Child relation system, Kaye Valprobe system, LAF, Dynamic passbox, new RM store, Warehouse, Stability Chamber etc. Development and execution of validation approch for existing utilities modification activity. Preparation of recommandation for validation and qualification outcome and ensure incorporation of CPP and CQA in to Batch Manufacturing record. Planning and development of Filter validation of produts. Participate in Internal Quality Audit as a Lead auditor. Risk assessment of manufacturing process and equipement qualification by FMEA tool. Raise & Support the closure of Change Control Notes, Deviations, incidents and CAPA related to validation and qualification. Review of protocol and report of Process validation, Cleaning validation and calibration certificates. Audit Exposure : ANVISA, CDSCO, Gulf Countries (GHC) Audit.--
QA officer 10/2014 - 04/2016
Zydus BSV, Ahmedabad, Gujarat India
Industry: Pharmaceutical industry
Handling of validation and qualification activity.
Develop, plan and track validation, qualification and calibration plan. Execute periodic qualification of various equipment and utilities like HVAC, Pure steam, Autoclave, Tunnel, Washing, Filling and Stoppering, Sealing machines, RABS, Sterility Isolator, Unidirectional air flow devices, qualifications for new under development products. Project work exposure for Initial Qualification of new facility including AHUs, LAFs, Area, Air compressor, Manufacturing Skids for Liposome preparation, Extrusion system, Ultra Filtration system, Kaye Validator and qualification of modified utilities lines (WFI, Pure steam, Purified water, HW and CW). Support to achieve cGMP, effective quality management in all levels of process. Participation in media fill study. Audit Exposure: 1 USFDA, 1 German FDA, USA Customer’s Audits.--
Senior officer QA 08/2012 - 10/2014
Claris Injectable Limited, Ahmedabad, Gujarat India
Industry: Parenteral industry
Joining as a fresher in validation department
Preparation of validation and calibration calendars for yearly and monthly activity. Execution of process validation, cleaning validation, temperature mapping, calibration activity and equipment qualification etc. Analysis of process validation and cleaning validation samples. DEHT study of different manufacturing lines and trace and swab analysis study for cleaning validation development. Audit Exposure : MCC (South africa), INVIMA (Colombia), GHC Audit.--

Shree dhanvantari college of pharmacy 09/2010 - 05/2012
Surat, Gujarat, India
Degree: Master's Degree
Major:Quality assurance
Completed M.Pharma in Quality Assurance specialization with 8.46 CPI out of 10 CPI. Have completed project work for testing method development and published in journal.

Sumit Pipaliya