Hiring Candidates for APITORIA PHARMA PRIVATE LIMITED (100% subsidary of Aurobindo Pharma Limited) Hyderabad Cluster to fill the following Positions in API Division.
Sound knowledge of analytical method development and Method validation using HPLC as per guidelines. Knowledge of calibration and operations of all equipment like balance, ph meter, in analytical operation.
Responsible for reviewing batch manufacturing, monitoring process steps, and reviewing documentation. Additionally, support in handling deviations, change control, and CAPA management, internal and external audits to maintain compliance.
Preparation and review of Protocol as per sponsor and various regulatory requirements. Preparation and review of Informed Consent Document in English and vernacular language according to protocol.
Developing India-specific Artwork, Support to Regulatory dossier preparation and submissions like New drug applications, Site registration, Clinical trials and Import licence. Managing Registration samples right from dispatch of samples till the report.