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Are you a passionate Quality Assurance professional looking to grow your career in the pharmaceutical industry? We are hiring a Junior Team Member – QA to join our dynamic team in Bommasandra, Karnataka. This is a fantastic opportunity to work in a challenging and rewarding environment, ensuring compliance with global regulatory standards and driving continuous improvement initiatives.
Job Purpose
As a Junior Team Member – QA, you will be responsible for reviewing the compliance level of the site for deficiency responses, preparing master validation protocols, and ensuring adherence to company quality policies and regulatory guidelines. Your role will be critical in maintaining cGMP standards and supporting regulatory inspections.
Key Accountabilities
- Deficiency Response Management:
- Collate, review, and provide work plans for deficiencies to ensure timely responses to regulatory authorities.
- Master Validation Protocol & Report Review:
- Ensure timely execution of validation batches and submission of documents to address deficiencies.
- Annual Product Quality Review:
- Review reports for completeness and data accuracy to ensure cGMP compliance and audit readiness.
- Technical Agreements:
- Review and issue regulated market technical agreements for batch execution as per customer requirements.
- Document Management:
- Receive and distribute approval certificates, dossiers (TDP & RAP), and development reports for smooth execution of new products.
- Regulatory & Customer Inspections:
- Coordinate with auditors and site teams to meet regulatory expectations and secure GMP approvals.
- Compliance to Audit Observations:
- Prepare final drafts of compliance reports to ensure alignment with cGMP requirements and avoid regulatory actions.
- MHRA, UK Interim Updates:
- Collect, compile, and review raw data for timely submission of interim updates to corporate for risk-based inspection planning.
- Continuous Improvement:
- Drive initiatives in CQA to enhance cGMP adherence and operational efficiency.
- Error-Free Submissions:
- Review product licenses, certificates, and applications to ensure timely and accurate submissions.
- Regulatory Inspections Support:
- Assist in CDSCO and state FDA inspections to ensure GMP compliance and secure product licenses.
Education & Experience
- Education: B.Pharma or M.Sc in a relevant field.
- Experience: 2 years of experience in a Quality Assurance department within the pharmaceutical industry.
Key Competencies & Skills
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Job Location & Shift Hours
- Location: Bommasandra, Karnataka
- Shift Hours: Standard working hours (details to be discussed during the interview).
Why Join Us?
- Be part of a globally recognized organization committed to quality and innovation.
- Work in a collaborative and supportive environment that encourages professional growth.
- Contribute to meaningful projects that impact global health and safety standards.
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