Recruitment as EXECUTIVE / SENIOR EXECUTIVE – DSP/USP MANUFACTURING

Intas Pharma:

Intas is a leading, vertically integrated global pharmaceutical formulation development, manufacturing, and marketing company. Intas is committed to challenging the unmet medical and societal needs through a comprehensive pharmaceutical value chain spanning across the world.

Intas has set up a network of subsidiaries, under the umbrella name of Accord Healthcare to operate in global markets. Over the years, Intas has grown both organically and via acquisition, expanding its product portfolio and operations year on year. It is currently present in more than 85 countries worldwide with robust sales, marketing and distribution infrastructure in markets like North America, Europe, Central & Latin America, Asia-Pacific as well as CIS and MENA countries. Intas’ remarkable success in North America and European operations have helped us emerge as a global brand in the world’s largest pharmaceutical markets.

The purpose of this job as an Executive or Sr. Executive in DSP and USP Manufacturing (Cell Culture and Microbial) is likely to involve overseeing the production process for biological products using chromatography and TFF systems, as well as ensuring compliance with quality management systems (QMS) and cGMP regulations. The main skill required for this role would be knowledge and experience with these systems and a good understanding of cGMP guidelines.

The roles and responsibilities listed include:

• Carrying out buffer preparation and purification operations for commercial, test and validation batches
• Ensuring compliance with cGMP guidelines in the functional area as defined by SOPs
• Performing equipment and instrument qualification and re-qualification
• Preparing, revising, and finalizing SOPs and c-GMP documents for DSP/USP operations
• Maintaining general area cleanliness and sanitation compliance in the DSP/USP area
• Properly documenting batches according to protocols and procedures
• Ensuring online trending of all products is maintained
• Carrying out operations for commercial, test, and validation batches in DSP/USP CC and Microbial-based products
• Properly executing and processing cell culture operations for commercial, test and validation batches
• Ensuring compliance with cGMP guidelines in the cell culture area as defined by SOPs
• Preparing and revising equipment and process-related SOPs for the cell culture area
• Maintaining general area cleanliness, sanitation, and compliance with bio safety policies in the cell culture area
• Learning media preparation activities for cell culture/microbial operations
• Qualifying new equipment and preparing qualification documents (URS, DQ, IQ, OQ and PQ).

Qualifications required:

• The qualifications required for the role include a MSc, B.Tech, or M.Tech degree.

Competencies required:

• The specific competencies required include being action-oriented, having a customer focus, being able to deal with ambiguity, having strong problem-solving skills, and being able to manage time effectively.

Relevant skills/ Industry experience:

• The ideal candidate should have 2-7 years of relevant industry experience in the biopharma industry.
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