Hyderabad

Personnel handling this profile will be responsible for performing reactions as per the requirement of the project. They are also responsible for documenting the observations in relevant note books. They are to follow instructions from the supervisor and work in a group (or individually) to accomplish the tasks in a timely and efficient manner. 

Ensure process is in place to maintain the PV QD Training Matrix, training curriculum updated. Ensure global traceability and monitoring of investigations of all identified quality gaps, quality risks and ensure that Corrective and preventive Action Plans are implemented in timely manner.

The Quality Manager responsible for handling technical complaints is tasked with investigating and managing technical complaints raised by clinical investigator sites regarding Investigational Medicinal Products and Medical Devices. Support data integrity incidents, manage escalations, and contribute to global DI networks and initiatives.

PhD or equivalent degree or having 3 years of research, teaching and design and development experience after MTech, MVSc, MPharm with atleast one research paper in Science Citation Indexed journal. 

Verify the accuracy of transcribed data by cross-referencing with original sources and ensure an accurate presentation of data in the report. Ensure that all transcribed data complies with internal quality standards and external regulatory requirements.

QA Specialist will serve as QA technical subject matter expert for CSV process, such as MES, KNEAT, DCS, including but not limited to GMP enterprise systems, manufacturing systems and computerized equipment, laboratory systems and computerized equipment and validation software tools.

Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.

MSc. with 1st Class in Genetics,Human Genetics, Life Sciences, Biochemistry from recognized university and suitability bases on CSIR, UGC, ICMR, DBT, etc.

Method validation, verification and transfer to Quality control lab for OSD and PFOS formulations. Development, optimization and validation of analytical methods to support OSD formulation ANDA.