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The Manager / Assistant Manager – CQA will be responsible for leading Quality Assurance functions across Daman, Tarapur, and Jammu plants, ensuring compliance with global regulatory standards including USFDA, MHRA, WHO, and TGA. The involves overseeing Quality Management Systems (QMS), audits, SOPs, validations, CAPA, and data integrity initiatives. The candidate will focus on standardizing processes, driving quality metrics, and supporting new product introductions while ensuring continuous improvement and regulatory readiness across all sites.
Roles & Responsibilities:
- Lead and oversee Corporate Quality Assurance functions across multiple manufacturing plants.
- Ensure compliance with global regulatory requirements including USFDA, MHRA, WHO, and TGA guidelines.
- Manage and strengthen Quality Management Systems (QMS) across all locations.
- Develop, review, and standardize SOPs, policies, and quality procedures.
- Oversee internal and external audits, regulatory inspections, and compliance readiness.
- Drive CAPA (Corrective and Preventive Actions) implementation and effectiveness monitoring.
- Ensure robust data integrity practices and compliance with regulatory expectations.
- Lead validation activities including process, cleaning, equipment, and method validations.
- Monitor and analyze quality metrics and KPIs to drive continuous improvement.
- Standardize quality processes and systems across all manufacturing units.
- Support new product introductions (NPI) with quality assurance inputs and compliance checks.
- Coordinate with cross-functional teams including production, QC, regulatory, and engineering.
- Review and approve batch records, quality documentation, and change control processes.
- Manage deviations, investigations, and risk assessments effectively.
- Ensure timely closure of audit observations and compliance gaps.
- Provide training and guidance to teams on quality systems and regulatory requirements.
- Lead vendor qualification and quality audits where required.
- Maintain documentation, reports, and MIS for management review.
- Drive continuous improvement initiatives and quality culture across the organization.
- Stay updated with evolving regulatory guidelines and industry best practices.
- Ensure adherence to company policies, ethical standards, and compliance frameworks.
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About Medley Pharmaceuticals Ltd
Medley Pharmaceuticals Ltd is a pharmaceutical company engaged in the development, manufacturing, and marketing of a wide range of pharmaceutical products.
The company focuses on delivering quality-driven and affordable medicines to meet the evolving healthcare needs of patients and medical professionals.
Our Story
Medley Pharmaceuticals Ltd was established with a vision to provide reliable and effective pharmaceutical solutions.
Over the years, the company has expanded its presence across domestic and international markets, building a reputation for quality, consistency, and trust in the pharmaceutical industry.
Our Mission
The company is committed to:
- Delivering high-quality and affordable pharmaceutical products
- Ensuring strict adherence to regulatory and quality standards
- Expanding access to essential medicines across markets
- Continuously improving processes and product offerings
Our Vision
To be a globally recognized pharmaceutical company known for quality, innovation, and excellence in healthcare solutions.
Our Services / What We Offer
Medley Pharmaceuticals Ltd offers a diverse portfolio of pharmaceutical products and solutions, including:
- Development and manufacturing of pharmaceutical formulations
- Marketing and distribution of medicines
- Therapeutic solutions across multiple healthcare segments
- Focus on quality assurance and regulatory compliance
Why Choose Us
The company stands out for its commitment to excellence:
- Strong focus on quality and compliance
- Established presence in domestic and international markets
- Experienced team and industry expertise
- Commitment to affordability and accessibility
- Continuous improvement in products and processes
Our Team
Medley Pharmaceuticals Ltd is supported by a team of professionals dedicated to maintaining high standards in manufacturing, quality control, and operations.
Their expertise ensures consistent delivery of reliable pharmaceutical products.
Infrastructure / Technology
The company utilizes modern manufacturing facilities and advanced technologies to ensure the production of high-quality medicines.
Its infrastructure is designed to meet regulatory requirements and support efficient operations.
Our Commitment
Medley Pharmaceuticals Ltd remains committed to delivering safe, effective, and high-quality pharmaceutical products while maintaining strong ethical standards.
The company continuously works towards innovation, quality enhancement, and improved healthcare outcomes.
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