Harshal Rairkar
Bio-analytical Review & Study | Project Management | Laboratory Operations | R&D | Documentation Quality Management | Training & Development | Team Management | Business Developmen
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About
Overall 15 years of experience in BA/BE studies. Expertise in maintaining systems in compliance with required guidelines or SOPs.
Handling
Client to meet satisfaction. Timely responding to the Queries received from sponsor/ regulatory agencies. Problem solving skills. To fulfill GLP requirements during conducting analytical and bioanalytical activities in preclinical studies. Hands on experience for HPLC, LC-MSMS and all other analytical instruments.
Experience
Business Development Manager - RegVision Pharma Consulting Ltd - UK
Responsible for identifying new business opportunities, forging partnerships, managing client relationships, and expanding market share in pharmaceutical and clinical research domains (CROs, biotech, etc.)
- Present service offerings (e.g., clinical trial management, regulatory support, drug development services)
- Prepare and deliver proposals, quotes, and contracts
- Analyze industry trends, competitors, and potential markets
- Develop go-to-market strategies for clinical and pharma service lines
- Build and maintain strong relationships with decision-makers in pharma and healthcare organizations
- Act as the liaison between internal project teams and external clients
- Negotiate and secure strategic partnerships or collaborations (e.g., with CROs, clinical sites, laboratories)
- Track progress and report KPIs to senior management
Head of Department - Analytical and Bioanalytical Department - PRADO GLP certified Lab
(2024-02 - 2024-07)
Preclinical studies. Responsible for all departmental daily activities.
- Responsible for method development, method validation and studies are conducted as per GLP requirements
- Handling of HPLC, LC-MSMS and all other analytical instruments
- To guide and trained the lab personnel for respective job as per requirement
- To prepare and review method SOP, validation protocol and study protocol as per sponsor requirements
- To perform dose formulation studies, eco toxicological studies
- To perform Extractable and Leachable studies
- To perform bioequivalence studies for pre-clinical projects
- To conduct vendor audits for site selection
- To give response for sponsor queries and regulatory agencies
Bio analytical Quality System Group Leader (Deputy Manager) - Veeda clinical research, Ahmedabad Gujarat - Ahmedabad, Gujarat
(2023-09 - 2024-02)
- Responsible for all system related activities and auditing
- Client handling for visits or providing information related to organization
- Responsible for sponsor/visitor and regulatory agency lab tour visit
- Resolving sponsor/visitor and regulatory agency pre-qualification audit observations
- Timely responding to audit observations and queries
- Maintain tracker for audit observation and CAPA
- Ensure GCP/ GLP training records are updated
- Identify system or SOP gap analysis as per guidance or guidelines
- Ensure RFI are submitted on time
- Inter/ Intra department co-ordination with team members to respond queries
- Review SOP deviation in Kriya software app
- To review out of specification (OOS) records
- To prepare audit observation Excel for Quality review meeting (QRM)
- Review recorded data using LES (digital platform) software
- To review audit trails and documents for traceability
- To review calibration/ preventive and maintenance records
- To review master equipment list/ calibration schedule
- To review method validation/ study reports
- To review OGD tables/ clinical summary report
- Discuss with clients regarding report related queries
- To conduct pre-qualification audits
- To manage and guide team members for respective responsibilities
- To ensure Archival and documentation control team are performing responsibilities as per SOP
Sr. Bioanalytical quality Monitor (Deputy Manager) - ENEM NOSTRUM REMEDIES
(2019-10-07 - 2023-09-14)
- Managing team of four quality control specialist for data review, SOP revision and all lab related activities
- Managing team for report preparation officers
- Responsible for Quality control review data against SOP's
- Project management meetings to share timelines for raw data and final report sharing to QA department
- Review of guidelines for reference to revise SOP's as per current regulatory
- Finalizing investigations, events and note to files
- Review compliance and CAPA for observation received from sponsor/ regulatory audits
- Proficient in methods and practices of bio-analytical analysis
- Ability to prepare technical reports. Demonstrate a consistently high level of quality of work
Senior Executive-Reviewer (Bio-analytical) - Teva Pharmaceuticals
(2010-08 - 2019-01)
Successfully functioned as Reviewer for all bio-analytical study related activities.
- Provided oversight and conducted project throughout its life including method development, method validation, and sample analysis. Interfaced with the customer to resolve sample discrepancies
- Spearheaded team of team of 4-5 Group Leaders and 8-10 team members involved in LC-MS/MS API 6500
- Significantly contributed in conceptualizing various sensitive methods for inhalation molecules
- Worked in close liaison with the Technical Writing and QA to ensure projects are completed on schedule
- Reviewed validation and bio-analytical reports for completeness
- Maintained all communication with customers providing daily updates on all active projects while being vigilant for opportunities to earn additional business
- Monitored the progress of all assigned projects and alert management if work falls behind schedule
- Provided regular project status updates to management
- Participated in weekly scheduling and revenue update meetings and provide updates on project progress
- Submitted accurate weekly assessment of resource requirements for scheduling purposes
- Prepared validation and sample analysis plans
- Addressed issues from QC and QA review for run binders. Conducted thorough investigations of all failed runs
- Lead method troubleshooting investigations. Assembled group of pertinent technical resources and write up investigation report. Reviewed data (run binders, data tables, etc) for regulatory compliance and scientific quality
- Key role in revising all SOP`s in the department and successfully organized training program for the same
- Involved in receiving the working/ reference standard and after documenting it make available for laboratory use
- Interfaced with various departments establishing ensuring smooth workflow
- Active participation in various agency audits; successfully cleared USFDA audit without any observation for Projects while functioning as Group Leader
Analyst and project Incharge - Reliance Life Sciences
(2006-10 - 2010-08)
Worked as analyst and project Incharge for all bio-analytical method validation and study related activities.
- Hands on experience using LC-MSMS API 2000, 3200, 4000
- Skilled in sample preparation for biological matrix using different extraction methods
Analyst - Accutest Research Laboratories
(2005-06 - 2006-03)
Worked as analyst for all bio-analytical method validation and study related activities.
- Hands on experience using HPLC and LC-MSMS API 2000
- Skilled in sample preparation for biological matrix using different extraction methods
Education
MBA - Clinical Research - National Institute of Management (2007)
B.Sc - Microbiology - Modern College, Vashi (2003)
Higher Secondary Certificate - T.H.Wajekar Junior College (2000)
Senior Secondary - Native Institute of High School (1998)
