Senior Bioprocess Quality Assurance Specialist

3 weeks ago

Bengaluru, Karnataka, India Lifelancer Full time
About the Role

We are seeking a highly skilled Senior Bioprocess Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring the quality and compliance of our bioprocess equipment.

Key Responsibilities
  • Work with operations personnel on quality and safety issues to ensure timely resolution and minimal disruption to business operations.
  • Strategic planning for qualification aiming to complete as per customer promised timelines, ensuring seamless delivery of products and services.
  • Lead and assist with Factory and Site Acceptance (FAT/SAT) testing and IQ/OQ/PQ including documentation review and reporting, guaranteeing accuracy and completeness.
  • Perform detailed Root Cause Analysis for customer complaints pertaining to Qualification, identifying areas for improvement and implementing corrective actions.
  • Participate in development of Qualification team, GEMBA meetings, sprints, and log progress through completion, fostering a collaborative environment and driving results-oriented initiatives.
  • Ability to take-around BIO Process equipment with customers during Factory Acceptance test, building strong relationships and ensuring customer satisfaction.
  • Oversee the perfection of Qualification protocols, ensuring adherence to regulatory requirements and company standards.
Main Responsibilities & Tasks
  • Inspect or verify services are compliant with applicable requirements, maintaining high levels of quality and integrity.
  • Plan, organize and conduct audits/assessments of supplier's systems, processes and products, ensuring alignment with industry standards and best practices.
  • Work with services to close out any audit findings, addressing concerns and implementing corrective actions.
  • Document and report audit/assessment results, providing transparent and accurate information to stakeholders.
  • Facilitate quality issues in conjunction with key stakeholders, resolving day-to-day problems and escalating critical issues.
  • Perform effective containment and problem resolution for all non-conformances, minimizing disruptions and maintaining customer confidence.
  • Report and assess status of service performance, identifying areas for improvement and implementing data-driven solutions.
  • Provide education and coaching on quality systems, regulatory compliance issues and company initiatives, promoting a culture of excellence and continuous learning.
  • Provide support for product development, ensuring quality and compliance throughout the product lifecycle.
Qualification & Skills
  • Bachelor degree in a relevant science, engineering or related subject, demonstrating a solid foundation in scientific principles and methodologies.
  • Minimum 5 years' experience in a quality and assurance development ideally within the biomedical or pharmaceutical industry, showcasing expertise and knowledge in quality assurance principles.
  • Professional Certification — In-depth knowledge of Quality auditing, and regulatory standards, demonstrating expertise and commitment to ongoing learning and professional development.
  • Good Technical Engineering knowledge, including ability to understand engineering drawing and standards, ensuring a deep understanding of technical aspects and regulatory requirements.
  • Ability to develop realistic work plans, set personal goals that align with company goals, and prioritize tasks to achieve objectives.
  • Well-organized and methodical, with a superb attention to detail, ensuring accuracy and precision in all aspects of the job.
  • Ability to prioritize and manage daily assignments, balancing multiple tasks and responsibilities while meeting deadlines.
  • Excellent written and verbal communications skills to represent the company professionally, fostering strong relationships with internal and external stakeholders.
  • Establish and maintain positive working relationships with all in-and external interfaces, promoting a collaborative and inclusive work environment.
  • Fluent in English, facilitating effective communication and collaboration across diverse teams and stakeholders.
Salary Information

The estimated annual salary for this role is $120,000 - $180,000 depending on qualifications and experience.

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