Home Engineering Executive/Sr.executive - Equipment Validation | Alembic Pharma | Vadodara

Executive/Sr.executive – Equipment Validation | Alembic Pharma | Vadodara


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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The publicly listed entity that manufactures and markets generic pharmaceutical products across the globe has grown by leaps and bounds over the last century.

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 an 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.

Positions: Executive / Sr.executive – Equipment Validation (Injectable)

Location: Vadodara, Gujarat, India

Job Description:

  • Must have exposure of working in a sterile manufacturing unit.
  • To review of URS, FAT, SAT, Impact assessment, Risk Assessment, DQ, IQ, OQ, PQ and other Qualification documents.
  • Responsible for all operations CF department equipment/area qualification.
  • Responsible for process validation and cleaning validation of different products proposed for manufacturing.
  • periodic performance verification of the equipment area process.
  • Updating/preparing the site master validation plan.
  • To perform the FAT for applicable equipment and utilities.
  • To review of validation related activities like Aseptic Process simulation (Media Fill), Process Validation, and Cleaning Validation.
  • To review of Incidents, Change Control, Risk Assessment, CAPA, and other quality management system documents.
  • To be a part of a cross-functional team for investigation procedures for observation of internal and external audits.

Qualification: Appropriately Qualified

Experience: 2-7 Years

Salary: Negotiable

Contact Details:

Ms. Bhavna Kadam

bhavna.kadam@alembic.co.in, engg@alembic.co.in

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