Quality Assurance & Regulatory Affairs Hirings at Genuine Biosystem
Quality Assurance & Regulatory Affairs Hirings at Genuine Biosystem
Genuine Biosystem Pvt. Ltd., a leading name in the IVD manufacturing industry, is actively seeking talented individuals for the Senior QA/RA Executive role at their facility in Chennai, Tamil Nadu. This is a promising opportunity for professionals with expertise in quality assurance and regulatory affairs, particularly in the IVD or pharmaceutical sector.
Why Join Genuine Biosystem?
At Genuine Biosystem, we aim to revolutionize healthcare diagnostics with high-quality, reliable solutions. Joining our team means being part of an innovative company committed to delivering excellence in the IVD manufacturing industry.
Current Openings
Position: Senior QA/RA Executive
Location: Chennai, Tamil Nadu
Experience Required: Minimum 3 years in the IVD or pharmaceutical industry
Educational Qualification:
- Bachelor’s degree in Life Sciences or related fields
- Candidates with prior experience in healthcare or diagnostics are preferred
Key Responsibilities
👉 Never Miss a Pharma Job Again
💼 Join our LIVE WhatsApp Group & Get Instant Updates. 📢 Click below to join:
📱 Join Click HereAs a Senior QA/RA Executive, you will:
- Collaborate with regulatory agencies, including State and Central Licensing Authorities, on key matters.
- Prepare, review, and file premarket documents for global registrations.
- Develop regulatory strategies for new or modified products.
- Prepare document packages for international regulatory submissions.
- Perform internal audits as per ISO 13485, MDSAP, USFDA, EU IVDR, and IMDR standards.
- Conduct gap analyses, remediation, and submission of documents as per EU IVDR 2017/746.
- Oversee process, product, and equipment validation (IQ, OQ, PQ).
- Author and review regulatory and quality system procedures, ensuring timely updates.
- Monitor changes in the regulatory landscape and assess their impact.
- Manage QA and RA team coordination to ensure seamless workflows.
Skills & Competencies
To excel in this role, you should possess:
- Strong communication and interpersonal skills.
- The ability to work independently and within a collaborative team.
- Familiarity with global regulatory standards and documentation requirements.
Application Process
If you meet the qualifications and are passionate about working in the healthcare or diagnostic industry, we encourage you to apply.
Send your CV to:
📧 admin-hr@genuinebiosystem.com
📧 info@genuinebiosystem.com