Hetero is a globally recognized, integrated pharmaceutical company renowned for its robust research, development, and manufacturing capabilities. With a strong focus on generic medicines, Active Pharmaceutical Ingredients (APIs), and biologics, Hetero has established itself as a key player in the global healthcare landscape. The company is committed to delivering high-quality, affordable medicines across multiple therapeutic areas.
Hetero’s state-of-the-art R&D center in Hyderabad is a hub of innovation, driving product development, process optimization, and lifecycle management. The organization prides itself on its adherence to stringent Quality Management Systems (QMS), cGMP compliance, and a culture of scientific excellence and integrity. A career at Hetero means being part of a team that is dedicated to making a difference in patients’ lives worldwide.
Job Description: Executive – DQA (Formulation R&D)
As an Executive in DQA (Development Quality Assurance) for the Formulation R&D division, you will play a critical role in bridging the gap between product development and quality compliance. Your primary responsibility will be to ensure that all formulation development activities and documentation meet global regulatory standards.
Key Job Responsibilities:
- Perform a thorough review and evaluation of Formulation Development Documents for accuracy and regulatory compliance.
- Assess critical documents including Master Formulation/Process Control (MFC/MPC), Product Development Reports (PDR), and technology transfer/scale-up reports.
- Ensure that the Formulation Laboratory operations strictly adhere to established GMP (Good Manufacturing Practices) and SOP (Standard Operating Procedure) guidelines.
- Support and manage Quality Management System (QMS) activities, including handling deviations, CAPA (Corrective and Preventive Actions), and internal audits.
- Collaborate effectively with Formulation Scientists, Analytical R&D teams, and Production units to ensure a seamless product development and approval process.
- Maintain comprehensive and audit-ready documentation to support regulatory submissions (like ANDA, NDA) and product lifecycle management.
- Actively participate in and contribute to continuous improvement initiatives for formulation processes and quality systems.
Eligibility Criteria & Qualifications
Educational Qualification:
- M.Pharm in Pharmaceutics is mandatory.
Experience Required:
- 2 to 5 years of relevant experience in pharmaceutical formulation development or a quality assurance role within a pharmaceutical R&D environment.
Essential Skills & Competencies:
- Strong understanding of pharmaceutical product development and formulation processes.
- In-depth knowledge of cGMP, QMS, and global regulatory compliance requirements for pharmaceutical R&D.
- Excellent documentation and analytical review skills with a keen eye for detail.
- Effective communication and team collaboration abilities.
- Proven capability to work under tight deadlines and manage multiple documentation tasks efficiently.
Job Location & Type
- Work Location: Hyderabad, India
- Job Type: Full-time, Permanent Role
- Salary: The compensation package will be competitive and commensurate with the candidate’s experience and industry standards.
How to Apply for the Executive DQA Role at Hetero
Interested and eligible candidates can apply for this Executive DQA job in Hyderabad by following these steps:
- Prepare an updated copy of your resume/CV.
- Send your resume via email to the designated contact.
- Use the subject line: “Application for Executive – DQA (Formulation R&D) – [Your Name]”.
Email your resume to:
vijaybabu.r@hetero.com