Senior Manager
6 days ago
Company Description
CORONA Remedies Limited, formerly known as CORONA Remedies Pvt Ltd, is a pharmaceutical company established in 2004. The company is recognized among the top 40 pharmaceutical companies. At CORONA, teamwork, openness, speed of action, and prosperity for every employee are key values. The mission is to ensure good health for individuals, society, and the nation through innovative, value-added, and evidence-based products.
Role Description
This is a full-time on-site role for a Senior Manager - CQA based at Plant. The Senior Manager - CQA will be responsible for overseeing the company's quality assurance processes. Day-to-day tasks include ensuring compliance with industry regulations, conducting audits, managing quality control teams, and implementing quality management systems. The role also involves continuous improvement initiatives, collaborating with cross-functional teams, and providing leadership in quality assurance practices.
Key Responsibilities:
- Vendor Qualification & Management
- Lead vendor qualification process including audits, assessments, and approval of raw material, packaging material, and service providers.
- Monitor vendor performance and compliance to GMP and regulatory requirements.
- Ensure periodic vendor requalification and maintain approved vendor list (AVL).
- Artwork Review & Control
- Oversee review and approval of packaging artwork to ensure compliance with regulatory, legal, and corporate requirements.
- Coordinate with cross-functional teams (Regulatory, Marketing, Production, Supply Chain) for artwork finalization and change management.
- Ensure accuracy, version control, and timely approval of artworks to avoid compliance risks.
- Quality Systems & Compliance
- Support corporate quality systems including change control, deviations, CAPA, and risk management.
- Ensure compliance with global regulatory guidelines (USFDA, MHRA, WHO, etc.) and internal quality standards.
- Prepare for and support internal/external audits and inspections.
- Documentation & Reporting
- Review, approve, and maintain quality-related documents and records.
- Ensure accurate and timely reporting of quality metrics to management.
Qualifications & Experience:
- M. Pharm / B. Pharm / M.Sc. (Chemistry / Life Sciences).
- 10–15 years of experience in
Corporate Quality Assurance
in a reputed pharmaceutical organization. - Strong knowledge of GMP, regulatory requirements, and quality management systems.
- Experience in vendor audits, vendor qualification, and packaging artwork review is mandatory.
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