Lead - Quality Assurance/Quality Control - Healthcare Industry
2 weeks ago
Title : Lead Quality Assurance/Quality Control
Location : Bangalore
Job Summary & Career Qualification : M.Pharm/M.Sc/M.Tech
Experience : 15-18 years experience quality assurance/quality control with atleast 5 years in lead role of a health care industry. Experience of handling Ayurvedic formulations will be an advantage
Preferred Age Group : 35-45
Excellent communication and leadership skills
Job Summary:
As a Quality Assurance (QA/ QC) Lead , you will be responsible for overseeing and ensuring the quality and compliance of our products, systems, and processes. You will lead a team of QC chemists located at various locations and work closely with cross-functional teams including development, product management, and regulatory compliance to deliver high-quality products that meet stringent industry standards.
Key Responsibilities
- Leadership and Team Management: Lead, mentor, and manage a team of QC chemists, ensuring their professional development and adherence to best practices. Allocate tasks, provide guidance, and conduct performance reviews.
- Quality Assurance Strategy: Develop and implement QA strategies, processes, and best practices to ensure the delivery of high-quality products. Create and maintain comprehensive SOP's, test plans and reports
- Test Planning and Execution: Design, execute, and oversee testing processes of all the products as per the specifications before release and set up frequency of external testing while ensuring that testing activities are aligned with project requirements and timelines
- Collaboration: Work closely with both internal and external stakeholders including the CMU's, R&D team, operations, and other stakeholders to understand requirements, identify potential issues, and provide feedback. Facilitate communication between teams to address and resolve quality concerns
- Compliance and Regulatory Standards: Ensure that all QA activities comply with relevant regulations and standards (e.g., AYUSH/ FSSAI/ FDA etc). Maintain up-to-date knowledge of industry regulations and integrate them into the QA process
- Defect Management and withdrawal: Identify, document, and track defects and issues and report/ escalate on time. Work with development teams to prioritize and resolve defects to record RCA and ensure implementation in future at CMU's.
- Continuous Improvement: Drive continuous improvement initiatives within the QA team and across the organization including the CMU's.
- Identify opportunities to improve product ratings
- Documentation: Maintain thorough and accurate documentation of QA processes, test results, and defect reports. Generate and present regular reports on quality metrics, testing progress, and team performance
Additional responsibilities
- Continuous improvement of the existing products
- Co-ordination with 3P manufacturer
- Alternate vendor development
- Technology transfer
- Ability to work collaboratively in a fast-paced, cross-functional environment.
- Detail-oriented with a commitment to delivering high-quality results.
- Adaptability to changing priorities and requirements
Expected knowledge/hands on experience
- Strong knowledge of QA methodologies, tools, and processes
- Experience with both manual and instrumentation techniques
- Familiarity with regulations and standards (e.g., AYUSH/FSSAI/FDA).
- Excellent leadership, communication, and interpersonal skills.
- Strong analytical and problem-solving abilities
- Working across boundaries with cross functional working with R&D, marketing and operations team including CMU's
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