A leading pharma Industry in Bengaluru, India seeking an experienced Senior Associate – Quality Assurance to join its Quality team in Bangalore. This is an excellent opportunity for quality professionals with hands-on experience in pharmaceutical quality systems, GMP compliance, regulatory documentation, and quality management.
Company: IncepBio
Job Title: Senior Associate – Quality Assurance (QA)
Location: Bangalore, Karnataka, India
Industry: Pharmaceutical Manufacturing | Biotechnology | Life Sciences
Job Type: Full-Time
Experience Required: 4–5 Years
The ideal candidate will play a key role in maintaining the organization’s Quality Management System (QMS), ensuring compliance with pharmaceutical regulations, supporting audits, and driving continuous quality improvement initiatives.
Job Responsibilities
- Develop, review, and maintain Quality Management System (QMS) documentation.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and applicable regulatory requirements.
- Plan, conduct, and support internal, external, customer, and regulatory audits.
- Prepare, review, and manage Standard Operating Procedures (SOPs), protocols, reports, deviations, Corrective and Preventive Actions (CAPA), and change control documentation.
- Perform quality risk assessments and implement continuous improvement initiatives.
- Support equipment qualification, process validation, and validation documentation activities.
- Coordinate supplier quality management activities and conduct vendor qualification and audits.
- Deliver quality-related training programs and mentor junior team members.
- Monitor, analyze, and report quality metrics to management for performance improvement.
- Ensure compliance with data integrity principles and quality system requirements.
Job Qualifications
- Bachelor’s or Master’s Degree in Pharmacy, Life Sciences, Biotechnology or a related discipline.
- 4–5 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or life sciences industry.
- Strong knowledge of GMP, GDP, Quality Management Systems (QMS), CAPA, deviation management, change control, validation, and regulatory compliance.
- Experience in internal audits, supplier audits, and regulatory inspections is preferred.
- Familiarity with data integrity requirements and pharmaceutical quality standards.
- Excellent documentation, analytical, communication, and problem-solving skills.
- Work with a growing pharmaceutical and biotechnology organization.
- Gain exposure to advanced pharmaceutical quality systems and regulatory practices.
- Collaborate with experienced quality professionals in a dynamic work environment.
- Opportunities for professional development and career growth.
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