Company Jobs

M.Pharm, B.Pharm, M.Sc, B.Sc ; Nitin is a rapidly growing Indian pharmaceutical company with a strong presence in Injectable manufacturing.

Hiring M.Pharm, B.Pharm, M.Sc for DQA and AR&D Department. R&D and AR&D Experience Also can attend.

M.Sc / B.Pharma / M.Pharma ; 2 to 8 years of experience into API / Intermediates Manufacturing.

Understanding of drug development processes and proficiency in quality principles driving drug development such as GMP and applicable regulations and policies.

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.

As a Senior Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of in Native treatments and therapies.