The legacy of Alembic Pharmaceuticals Limited (APL) dates back to over 100 years. Established in 1907 with an objective to develop and revolutionize the Pharmaceutical and Drug industry in the Indian subcontinent, Alembic Pharmaceuticals Limited today is one of the leading pharmaceutical companies in India.
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With an emphasis on innovation and technology, the company has established a state-of-the-art research facility – Alembic Research Centre (ARC)-including formulation research, and a 150-bed bioequivalence facility at Vadodara, Gujarat. Additionally, APL has recently invested in ultra-modern R&D center at Hyderabad. APL is one of the leading players in the industry to have invested about 11% of its turnover in R&D.
As a growth strategy, the company has aggressively started investing in the international generics market with successful ANDA and DMF filings. APL has also filings across Canada, Europe, Australia, South Africa & Brazil. The company caters to the rest of the world markets through branded formulation sales.
The company aims to explore opportunities in therapeutic areas such as Dermatology, Oncology, and Injectable Formulations. APL also has also co-promoted a company focused on the discovery and development of innovative, small molecule drugs that target signal transduction networks and ion channels for the treatment of cancer, inflammation, autoimmune diseases, and metabolic disorders.
Position: Executive: API Validation Method
Department: Central Validation Lab API ( HPLC/GC )
Location: Karakhadi, Vadodara Gujarat, India
- Perform analysis related to analytical method validation, cleaning validation, forced degradation study, pharmacopoeial evaluation for API.
- Preparing method validation protocols and reports.
- Perform method transfer activity.
- Thorough knowledge of related substance, assay, residual solvent, and PSD method validation as per ICH guidelines.
- Expert in handling and calibration of instruments such as HPLC, GC, Malvern Particle Size analyzer, UV, KF, IR, and other lab instruments.
- Aware of cGMP practices, must follow and maintain GLP.
- Expert in analytical raw data review for method validation, method transfer and instrument calibration.
- Knowledge of regulatory requirements.
- Knowledge of chromatographic software Empower 3.
- Able to maintain all Lab records, logbooks, calibration data, SOPs, training records etc.
- The Applicant must be comfortable working at Plant Location
Qualification: B.Sc/B.Pharma, MS/M.Sc
Experience: 3-6 Years, Minimum 2 Years of HPLC/GC
Ms. Madhura Mistry
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