BioMatrix Healthcare Pvt. Ltd.
Website:
biomatrixhealthcare.com
Job details:
Company Description
BioMatrix Healthcare Pvt. Ltd., headquartered in Ahmedabad, India, is a globally recognized pharmaceutical formulations company with operations in over 40 countries. Established in 2007, BioMatrix upholds a commitment to producing high-quality, affordable, and patient-centric medicines that meet international standards. With WHO-GMP, EU-GMP, and Health Canada-approved facilities, BioMatrix also complies with regulatory standards such as ANVISA, UKMHRA, and USFDA. The company is supported by a state-of-the-art R&D center with experienced scientists and manufacturing capabilities.
Role Description
The General Manager of Quality Assurance is a full-time, on-site role located at our headquarters in Ahmedabad. The role involves overseeing and ensuring compliance with regulatory standards across all aspects of production. Responsibilities include leading a team to implement quality management systems, conducting internal and external audits, managing regulatory submissions, overseeing product testing, ensuring adherence to GMP standards, and collaborating with R&D to maintain quality in product development. The General Manager will also be tasked with ensuring timely documentation, process validation, and training to maintain a high standard of quality.
Qualifications
- Proven expertise in Quality Assurance, regulatory compliance, and ensuring GMP adherence
- Experience with internal and external quality audits and submission of regulatory documents
- Strong leadership, team management, and training skills in quality management systems
- In-depth knowledge of bioequivalence studies, ICH guidelines, and stability testing
- Familiarity with manufacturing standards compliant with WHO-GMP, EU-GMP, USFDA, and other global regulatory authorities
- Technical proficiency in overseeing quality control processes and process validation
- Excellent communication skills and ability to collaborate cross-functionally
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, or a related field
- 10+ years of experience in quality assurance within the pharmaceutical industry
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