Tushar Patel

• 25+ years Associated with pharmaceutical industry for handling Manufacturing, Quality operations, Validations, cGMP-compliance, Training and Project management. This tenure included over ten years of senior leadership roles at global MNCs like Akron, Fresenius-Kabi, Wockhardt and RV Lifesciences
• Rich exposure in various dosage forms through Small Volume Injections (Ampoules / Vials/ Dry powders/ PFS/ Cartridges), Oral Dosages (Tablets, Hard gelatin & Soft gelatin capsules), Liquids (Oral & External) and External preparations (Ointments, Creams, Toothpastes and Lotions)
• Well versed with QMS, GMP, GLP, 21 CFR Part- 11,
• Projects:

- Participate in green field project at Akorn India (P) Ltd, Paonta Sahib, facility for Liquid small volume Injections (Ampoules / vials for Hormone Facility) and Dry Powder Vials (Carbapenem Facility).

- Participate in green field project at Wockhardt BioAG Dubai, Dry powder Vials & Lyophilization Injections

- Participate in green field project of Pharma Facilities (Nicholas Piramal (I) Ltd Baddi, facility for Solid & Liquid Oral dosage.

- Participate in green field project at Troikaa Pharma Ltd, Dehradun, facility for Liquid small volume Injections.

- Upucoming green field porject of Oncology injectable line at Shilpa Medicare Ltd Along with Quality and manufacturing activities;

- Leading and key person in projects team involved in design and execution of Injection and OSD plants right from inception.

• Commissioning and Qualification / Validation (C&QV) activities as per global benchmark for various formulation dosage forms.
• Leading the Operations in line with a best-in class Pharmaceutical Quality Systems (PQS) and representing the same in several regulatory inspections including USFDA, MHRA, TGA, EU-GMP, INVIMA, SAHPRA (MCC), WHO, ANVISA.
• Creating talent pipeline by setting in-house academies and by coaching key talents with respect to technical as well as managerial capabilities.
• Building robust product portfolio by establishing and leading manufacturing science and technology function in past organization.
• Building robust quality culture at the site with a structured approach of establishing and monitoring the key performance indicators.
• Data Integrity lifecycle management in past organizations and helped building sustainability of business operations.
• FDA remediation projects in past organizations with focused improvement in facilities, systems and people performance indicators.
• Development of Quality Management system for tracking, implementation and post effectiveness checks of CAPA elevated by deviations, incident, market complaint, OOS, OOT, failure investigation, internal audit or regulatory inspection
• Performed quality audits of Raw Material, Packaging Material & Finished product manufacturer and CFA facilities. Spearheaded Technology Transfer by review and approvals of technology transfer documents including method transfer.
• Playing a significant role in Manufacturing, Quality, Materials, Packaging & Labelling, Validation, Technology Transfer, Process Improvement, Planning & Implementation, Aseptic techniques and Microbiology, Facility & Engineering, and ensured necessary proactive measures have been taken to moderate and control the risk.
• Directing and observing technology transfer activities as well as contributing in various regulatory audits and providing compliance to audit observations Implementing Quality Management Systems with particular emphasis on cGMP, Data integrity, GDP, Quality Compliance through APQR, Self-inspection, and Internal Audits, Troubleshooting- Product Quality through product development overview and resource on all aspects of quality and QBD.
• Failure investigations and corrective preventive actions.
• Provided leadership for completing equipment / instrument/ utility life cycle from VMP to validation report, which includes URS, risk analysis, Qualification steps like review of FRS/DQ, FAT, IQ, OQ and PQ including part of CSV. Development, implementation and maintenance of validation standards with regulatory requirements (validation master plan, policies, procedures and protocol / reports).
• Training Lifecycle Management. Imparting, executing and monitoring the Training program. Imparted training to various level of pharmaceutical professionals.
• Recognized as a subject matter expert in the field Risk Management, Contamination Control, Process optimization, Aseptic Process design and simulation, Operational efficiency and People capability enhancement.
• An extensive hands-on experience in a wide range of pharmaceutical dosage forms including; Sterile Products: - Liquid, Lyophilized, Dry Powder, Suspension, Emulsion in Ampoules, Vials, PFS, SVP with Aseptic as well as TS products and Advanced Aseptic Processing (AAP) technologies as well as conventional technologies. Oral Solid/liquids Products: – Tablets, Capsules, Dry Syrups, Liquid Syrups with most complex as well as advanced technologies. Other Non-Sterile Dosage forms: -Semi Solid Dosage form products, cream, ointment, cram and liquid Preparations for external application.
• Provide quality oversight of the manufacturing, testing, and release of the organization products at CMOs

Certified Lead Auditor ISO 9001:2015