Maiva Pharma Private Limited (FDA Approved Sterile Injectables)
Website:
maivapharma.com
Job details:
Company Description
Maiva Pharma Private Limited, formerly Global Pharmatech, is a leading manufacturer of high-quality sterile injectables, operational since 1996. Based in Hosur, Tamil Nadu, its state-of-the-art facility spans 5 acres and includes integrated ampoule and glass vial production lines. With over two decades of expertise in sterile manufacturing, Maiva offers end-to-end pharmaceutical development and commercial production of sterile injectable products. Boasting certifications from USFDA, EU-GMP, Health Canada, and PIC/S, Maiva is recognized for its commitment to quality and regulatory compliance, emerging as a prominent name in the global injectables market.
Role Description
This is a full-time, on-site role based in Hosur for a Formulation Development Executive. The responsibilities include developing formulations for sterile injectable products, conducting literature reviews, optimizing product development processes, and ensuring compliance with international quality standards. The role involves working on analytical method development, stability studies, and supporting the regulatory submission process. Collaboration with cross-functional teams to ensure efficient project execution is a key aspect of this role.
Qualifications
- Experience in formulation development for sterile injectables, including familiarity with aseptic and terminal sterilization techniques.
- Proficiency in analytical method development, validation, and adherence to regulatory requirements.
- Strong research and literature review skills to support product and process innovation.
- Understanding of global regulatory guidelines, cGMP practices, and quality compliance requirements.
- Effective communication and teamwork skills to collaborate with cross-functional teams.
- A postgraduate degree in Pharmacy, Pharmaceutical Sciences, or a related field is preferred.
- Prior experience in regulatory submissions and sterile manufacturing processes is a plus.
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