JAYDIP PATEL

Highly qualified and experienced Qualified Person (QP) with over 17 years in quality control,and pharmaceutical manufacturing,quality assurance. Demonstrated expertise in regulatory compliance, Good Manufacturing Practices (GMP), Good laboratory practice ,product release, and batch record review. Proven ability to manage cross-functional teams, ensuring the highest levels of quality and safety in accordance with EU and international standards. Adept at troubleshooting, quality risk management, and maintaining relationships with regulatory agencies.

1 Currently Associated with Pharmazone as GMP auditor as manager

Approval of QMS activity and participation in investigation of appropriate CAPA Compliance of audit observation and do the audit

Proficient in formulating Regulatory Strategies for both pre-submission and post-approval submission like TGA.EUROPE,etc

Skilled in planning and executing Dossier submissions, as well as reviewing

Evaluation of quality trends Conducting of training programs

Having exposure of plant set up for EUGMP certificate in vietnam

Gained exposure in conducting vendor audits and adhere the regulatory compliance, assessment of the needs and spearheading in achieving

the compliance in line with current Quality Management System as well as to meet Current Regulatory requirements. Adept at implementing Quality Systems as well as enhancing Process Operations, thereby achieving the required Quality level.

• Responsible for ensuring compliance with GMP standards by performing internal and external audits of manufacturing processes and systems.
• Release batches for distribution after thorough review of batch records, manufacturing processes, and documentation to ensure conformity to GMP guidelines.
• Conduct GMP training for staff and suppliers to promote a culture of quality and compliance.
• Lead regulatory inspections and audits, coordinating responses to regulatory findings and implementing corrective actions as needed.
• Review and approve deviations and CAPA plans to ensure they address root causes and improve future compliance.
• Provide guidance on risk management processes and ensure proper documentation for all audit and compliance activities.

• Review and approve Analytical Procedures and OOS OOT Lab incident and deviation change control
• Establishing quality standards for implementing quality control systems
• Monitoring the proper documentation system as per GLP Criteria
• Identifying areas of quality concerns and taking corrective steps
• Conducting self-inspection audits throughout the plant
• Harmonizing firm SOPs to meet Regulatory Compliances

• Successfully completed data review within specified timeline
• Employed FDA requirements, considerations and recommendations as per In-House procedures

• Executing safe work culture at workplace
• 5S implementation at workplace

• Conducting breakdown maintenance, corrective maintenance and preventive maintenance for instruments
• Performing periodic checks to ensure performance of equipment

• Water system with Empower software
• Dionex make ultimate 3000 series with Empower and Chromeleon software
• Shimadzu make 2100 series with Empower software
• Polari meter
• Autotitrator
• Karl-Fisher
• TOC
• Refractometer

• Worked as plan executer in QC - Raw Material and finished product departments
• Performed analysis of exhibit raw materials, finished, and validation samples
• Evaluates and troubleshoots problems in analysis
• Maintained and verified all laboratory log books and analytical records
• Participated in method validation and method transfer activities

• Acquiring QMS data and incorporating in Track wiseS system
• Monitoring GMP compliance in quality departments
• Review of Standard Operating Procedures and conducting training sessions
• Responsible for issuance of Quality Control testing protocols/Documents
• Review and Authorization of validation protocols and reports
• Conducting Self inspection in Quality departments
• Investigation and conducting Root cause analysis

• Played a significant key role in HPLC Column regeneration
• MHRA, 11/10, USFDA, 04/11, MHRA, 01/12, MHRA, 03/12, USFDA, 04/13, WHO, 10/14, USFDA, 04/17, Internal Audits, 2019, USFDA, 2019, MHRA, 02/20

• Conducts compliance and non-compliance programs
• Adhere installation and qualification of Laboratory equipment
• Analytical data review and authorizing the certificate of analysis of finished product
• Accountable for Quality Risk Management

• English
• Hindi
• Gujarati