Job Opportunity: Executive / Senior Executive Roles at Apitoria Pharma
Job Summary
- Company: Apitoria Pharma Private Limited (a subsidiary of Aurobindo Pharma Ltd.)
- Positions Available: Executive and Senior Executive
- Departments Hiring: Analytical Research & Development (LC-MS) and Regulatory Affairs (RA)
- Location: Hyderabad
- Experience Required: 3 to 7 years in the pharmaceutical industry
- Key Requirements: Expertise in LC-MS methodology or API regulatory documentation
Company Overview
Apitoria Pharma Private Limited, a 100% subsidiary of Aurobindo Pharma Ltd., is a leading pharmaceutical organization committed to innovation and excellence. Based in Hyderabad, we are currently expanding our teams in both the Analytical Research & Development (AR&D) and Regulatory Affairs departments. We are looking for dedicated professionals to join our high-performing teams and contribute to our global standards of pharmaceutical quality and regulatory compliance.
Position 1: Executive / Senior Executive – Analytical Research & Development (LC-MS)
We are seeking an experienced professional to join our AR&D team. This role focuses on advanced analytical techniques and requires someone with a solid background in small molecule analysis.
Educational Qualifications:
- Master’s degree (M.Sc.) in Chemistry or M. Pharm in Pharmaceutical Analysis.
Experience:
- 3 to 7 years of relevant industry experience specifically in Analytical R&D with a focus on LC-MS.
Required Skills:
- Proven expertise in LC-MS method development, method validation, and batch analysis.
- Strong interpersonal, communication, and presentation skills.
- Ability to work in a collaborative, fast-paced environment.
Key Responsibilities:
- Lead and execute LC-MS/MS method development and validation projects.
- Perform impurity profiling for the identification of unknown impurities in small molecules.
- Ensure all laboratory instrumentation is calibrated according to standard operating procedures (SOPs).
- Provide technical support for routine analysis and advanced LC-MS testing.
- Maintain meticulous documentation in alignment with Good Documentation Practices (GDP).
- Ensure strict adherence to Good Laboratory Practices (GLP) and current regulatory requirements.
- Maintain a clean and safe laboratory environment, prioritizing safety standards and general housekeeping.
- Stay updated on the latest guidance documents and regulations issued by global health agencies.
Position 2: Executive / Senior Executive – Regulatory Affairs (RA)
We are looking for a detail-oriented professional to join our Regulatory Affairs department, focusing on API lifecycle management and global compliance.
Educational Qualifications:
- Master’s degree (M.Sc.) in Chemistry.
Experience:
- 3 to 6 years of relevant experience in API Regulatory Affairs.
Required Skills:
- In-depth knowledge of drafting and reviewing Module 3 documentation for APIs.
- Solid understanding of lifecycle management within the API regulatory framework.
- Clarity on post-approval changes and global regulatory guidelines.
- Strong verbal and written communication skills for cross-departmental and client interaction.
Key Responsibilities:
- Perform thorough evaluations of change controls.
- Draft and manage change notifications to customers, ensuring completion through to implementation.
- Manage new submissions, including the compilation and filing of Drug Master Files (DMFs) with global health agencies.
- Oversee lifecycle management tasks, including the compilation and submission of amendments and revisions to regulatory authorities.
Why Join Us?
At Apitoria Pharma, we foster a culture of professional growth and technical excellence. As a subsidiary of Aurobindo Pharma, we offer our employees exposure to world-class manufacturing and research standards, providing a platform to work on complex challenges and make a meaningful impact on the global pharmaceutical industry.
How to Apply
We invite interested and qualified candidates to apply for these positions. Please follow the instructions provided on our official recruitment posters to submit your application. Ensure your resume highlights your relevant experience in either LC-MS analysis or API regulatory documentation to help us match your profile to the correct team. We look forward to reviewing your application and exploring how you can contribute to the continued success of Apitoria Pharma.