SAP-Athena, GEODE, PHENIX, MS Project, JiRA, MS Office Suite, Triskell, Aras Innovator
BHAVESH PATEL
Project manager, Pen injectors and Autoinjectors
Vadodara
Summary
Dynamic and results-driven Project Manager with over 18 years of experience in the pharmaceuticals and medical devices sectors, offering a robust background in key account management, business development, and project management to consistently achieve operational excellence and drive business growth. Expertise includes project lifecycle management, quality assurance, and key account strategy within highly regulated environments such as ISO 13485, MDSAP, GMP, and ISO 15378. Proven ability to lead cross-functional teams, manage audits, and spearhead continuous improvement initiatives while maintaining a strong focus on client engagement, vendor management, and regulatory compliance. Actively pursuing PMP certification to further enhance project leadership capabilities and reinforce a commitment to exceptional customer satisfaction.
Overview
19
19
years of professional experience
1
1
Certification
4
4
Languages
Work History
Project Manager
Haselmeier India Pvt Ltd
01.2023 - Current
- Applied PMI-based project management methodologies to drive platform device development lifecycle.
- Directed cross-functional collaboration across R&D, Quality Assurance, and Regulatory Affairs to meet project deliverables.
- Oversaw vendor management and strategic sourcing to ensure supply chain efficiency and timely component delivery.
- Utilized project tracking tools (MS Project, JiRA, Triskell, Aras Innovator) to monitor KPIs, manage risks, and ensure adherence to timelines and budgets.
- Facilitated design control processes including design reviews, risk assessments, and technical issue resolution.
Business Development & Key Accounts Manager
Shaily Engineering Plastics Ltd
07.2021 - 12.2022
- Executed strategic account management for pharmaceutical CDMO and device clients, driving revenue growth and client retention.
- Led end-to-end business development lifecycle: market analysis, proposal development, contract negotiation, and post-sales support.
- Developed account-specific growth plans incorporating cross-selling, upselling, and portfolio expansion aligned with AOP targets.
- Negotiated high-value contracts ensuring alignment with profitability and compliance objectives.
- Acted as client advocate, coordinating with internal stakeholders (R&D, QA, SCM) to ensure project success and service excellence.
- Implemented structured client engagement frameworks including QBRs, strategic roadmaps, and feedback loops.
- Strengthened cash flow through proactive receivables management and audit readiness.
- Delivered injector-based device projects ahead of schedule, enhancing brand reliability and client satisfaction.
Deputy Manager – Quality Assurance
Shaily Engineering Plastics Ltd
06.2019 - 07.2021
- Maintained compliance with ISO 13485:2016, MDSAP and GMP standards for medical devices and primary packaging.
- Led internal/external audits including Notified Body inspections with zero critical findings.
- Managed validation lifecycle (IQ/OQ/PQ), revalidation, and risk-based quality planning.
- Directed QMS implementation and continuous improvement initiatives aligned with regulatory and customer requirements.
- Spearheaded CAPA programs using root cause analysis and effectiveness checks.
- Oversaw supplier qualification, audit programs, and performance reviews to ensure regulatory alignment.
- Promoted data-driven decision-making and mentored QA teams to foster a quality-centric culture.
Assistant Manager – Quality (Medical Devices)
Sanofi India Ltd
05.2013 - 07.2019
- Served as Management Representative for ISO 13485 and MDSAP compliance across site operations.
- Led product transfer and process validation activities including documentation and qualification protocols.
- Managed quality documentation (SOPs, STPs, specifications) and release processes for finished goods.
- Handled market complaint investigations, change control, and revalidation strategies.
- Supported vendor development, packaging innovation, and post-market surveillance initiatives.
- Played a key role in Platinum project deployment, enhancing cross-entity quality systems.
- Ensured HSE compliance and supported legal manufacturer obligations.
Executive – Quality Assurance (Pharmaceuticals)
Sanofi India Ltd
08.2006 - 04.2013
- Led supplier quality assurance programs and compliance training aligned with global standards.
- Managed CAPA, change control, and retrospective batch reviews through APQR analysis.
- Conducted IPQA and technical complaint investigations to reduce market complaints by 70%.
- Proficient in digital QMS tools: GEODE+, SAP-Athena, PHENIX.
- Championed site-wide engagement initiatives including ‘Quality Day’ and ‘Pharma Quiz’ to promote quality culture.
Education
Bachelor of Pharmacy -
University of Pune
01.2003
Skills
- Leadership & Strategy: Project Management, Key Account Management, Business Development, Strategic Planning
- Quality & Compliance: QMS Audit Management, ISO 13485, GMP, ISO 15378, MDSAP, Validation Lifecycle
- Operations & Collaboration: Vendor Management, Cross-functional Team Leadership, Client Engagement, Communication
Certification
Project Management Professional (PMP) Certification: Trained; Certification planned in 2026
Software
Timeline
Project Manager
Haselmeier India Pvt Ltd
01.2023 - Current
Business Development & Key Accounts Manager
Shaily Engineering Plastics Ltd
07.2021 - 12.2022
Deputy Manager – Quality Assurance
Shaily Engineering Plastics Ltd
06.2019 - 07.2021
Assistant Manager – Quality (Medical Devices)
Sanofi India Ltd
05.2013 - 07.2019
Executive – Quality Assurance (Pharmaceuticals)
Sanofi India Ltd
08.2006 - 04.2013
Bachelor of Pharmacy -
University of Pune
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