Hardik Patel
Brampton,ON
Summary
Successful pharmacy professional with 8+ years of experience in large-scale various types of pharmaceutical industries by improving and maintaining quality documents/processes and achieving company targets with leadership and team-building abilities.
Possess in-depth knowledge of cGMP, GLP, FDA, and ethical standards complemented by sound theoretical and technical knowledge of Quality Management System.
Overview
12
12
years of professional experience
Work History
Canadian Analytical Laboratory
08.2021 - 01.2023
- Manage all aspects of quality documentation issuance, returns, and achieve inclusive of all laboratory logbooks, notebooks, SOPs etc
- Issuance, logging, and closure of all laboratory OOS within time frame and co-ordinate with clients for relevant aspects
- Maintain the process for the execution, investigation and closing documentation of deviations and quality events occurrences
- Initiate, logging, and closure of change controls with impact analysis and supportive data
- Prepare SOPs, review drafted SOPs and implement the procedures
- Maintain overall CAPA program to include investigation, root cause analysis, corrective and preventative actions and documentation
- Perform mapping, calibration, and qualification of laboratory equipment such as stability chambers, fridge, freezer etc
- Review calibration data of instruments such as weights, pipettes, temperatures, thermometers, timers, hygrometers etc
- And update the calibration/qualification data
- Verify the qualification of lab instruments like HPLC, GC & Maintaining the data files
- Co-ordinate with service engineer for maintenance and trouble shootings
- Reviews various laboratory equipment logbooks and verifies entries for accuracy
- Prepare, evaluation and maintain training files for the employees based on respective training matrix
- Maintain all Quality documents in soft copies as well as in hard copy
- Regulatory submission of required documents in high quality, consistent, timely and complete manner
- Assist QA Manager in hosting GMP audits from clients and regulatory agencies such as Health Canada.
Aculife Healthcare Pvt. Ltd.
06.2016 - 02.2018
- Perform a quality review of critical documentation (e.g
- Batch Records, initial/bulk/in-process/finished product analysis reports, Quality Documents like APQR/Change Control/Deviations/OOS/Vendor Qualification) for accuracy, completeness, compliance, justifications
- Perform a final review of COAs and batch records to comply with respective SOPs/methods and specification within timeframe
- Based on it, give SAP release of particular batch product on daily basis for domestic as well as export market
- Resolve document queries with help of cross functional team and get approval and properly maintain as per GDP, GMP and regulatory requirements
- To perform Internal Audit of various departments as per audit planner & Check against SOP Compliance
- Also suggesting for proper and justifiable CAPA for mitigation of non-compliances observation and maintain record of it
- Regulatory submission of required documents in high quality, consistent, timely and complete manner
- Active Participation in all Regulatory Audit Preparation, Document Review and Audit Compliances
- Properly maintain the Audit files with the CAPA measures in controlled manner.
Claris Injectables Ltd.
02.2015 - 04.2016
- Handling of Change control, Deviation & OOS of all relevant departments with log maintaining, approval & closing of documents
- Properly investigate the actual causes of deviation and reported OOS and try to mitigate in further aspects
- Handling of Market Complaint with complete investigative updates to identify root cause of incident & provide justifiable CAPA
- Ensuring completion of suggested CAPA and its effectiveness during closing of complaints, deviations and OOS at timely manner
- To prepare & present a trend of market complaint, deviation & change control for management review meetings on monthly basis
- Provide training to team members with essential documents or using upgrade media source and make them more aware with quality concerns towards GMP, GDP and GLP norms
- Co-ordinate with cross functional team to complete the task as timely manner.
Cadila Pharmaceuticals Limited
06.2011 - 02.2015
- Prepare and review of departmental SOPs and also maintain crucial documents in controlled environments
- Preserve master copy of BMRs, BPRs, Specification/Methods, Validation Protocols etc and issuing controlled and uncontrolled copies as and when required
- Review, Maintain & Destruction of Batch Manufacturing Record, Batch Packaging Records and Batch Analysis Report
- Vendor Qualification Documents Review and also ensure the supplies of quality materials through approved vendor only
- Provide batch to batch and product to product line clearance as per proper checklist and try to avoid cross contamination in batch and ensure the quality of product on shop floor
- Recorded in-process checks data in batch records during manufacturing and packing stage
- Removal of bulk, in-process and FP samples in IPQA and sent to QC labs for analysis
- Verification of any deviation in approved procedure during batch manufacturing and immediately inform to superior for further course of action
- Ensuring quality of product by release of batch, based on IPQA activity and QC results
- To aware superior level with critical issues with the suggestions of problem solving.
Education
Master of Pharmacy - Pharmaceutical Quality Assurance
Rajiv Gandhi University
India06.2011
Bachelor of Pharmacy -
Rajiv Gandhi University
India06.2008
Skills
- Microsoft Windows XP
- Microsoft Office
- Internet Surfing
- Mailing
- SAP (System, application and product in data processing)
- Labware Database
- LIMS
Educational Record
- Master of Pharmacy, 2009 - 2011, 70.15
- Bachelor of Pharmacy, 2004 - 2008, 66.07
Audit Exposure
Well versed with a highly regulated environment and have faced several regulatory and customer audits like USFDA, TGA-Australia, MHRA-UK, WHO-Geneva, Ministry of Health of Ukraine, ANVISA-Brazil, Health Canada
Area Of Proven Performance
- Documentation & Review Section
- Internal Audit & Audit Compliance
- QMS (Quality Management System) activity
- Corporate Quality Assurance
- In-process Quality Inspection
- Organizational aspects
Languages
English
Full Professional
Timeline
Canadian Analytical Laboratory
08.2021 - 01.2023
Aculife Healthcare Pvt. Ltd.
06.2016 - 02.2018
Claris Injectables Ltd.
02.2015 - 04.2016
Cadila Pharmaceuticals Limited
06.2011 - 02.2015
Master of Pharmacy - Pharmaceutical Quality Assurance
Rajiv Gandhi University
Bachelor of Pharmacy -
Rajiv Gandhi University
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