Aurobindo Pharma Ltd. is an experienced and energetic candidate for the following job opening.
Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy, and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology, and cephalosporins, among others. Through cost-effective manufacturing capabilities and a few loyal customers, the company entered the high margin specialty generic formulations segment.
In less than a decade Aurobindo Pharma today has evolved into a knowledge-driven company manufacturing active pharmaceutical ingredients and formulation products. It is R&D focused and has a multi-product portfolio with manufacturing facilities in several countries. The formulation business is systematically organized with a divisional structure and has a focused team for key international markets. Leveraging on its large manufacturing infrastructure for APIs and formulations, wide and diversified basket of products, and confidence of its customers, it aims to achieve USD 2 billion revenues by 2015-16. Aurobindo’s nine units for APIs / intermediates and seven units for formulations are designed to meet the requirements of both advanced as well as emerging market opportunities.
Job Title: Executive / Sr. Executive – Production & Packing (Injectable)
Qualification: B. Pharma/M. Pharma
Work Experience: 4-8 Years
Work Location: Not Available
Skills: Compounding, Filling, Sealing, Packing, Must have exposure of Regulatory Audits
- Responsible for compounding, Filling, Sealing activities of Manufacturing Line.
- To verify/ensure the Indenting and issuance of Raw materials, Primary packaging materials as per the production plan through ERP.
- Receipt, Transfer, and Return of Raw materials required for Batch production.
- Monitoring of environmental conditions like Temperature, Differential Pressures, and Relative Humidity as per SOP.
- Monitoring of Cleaning and Sanitization of the areas as per SOP.
- Coordination with validation team during qualification and requalification of equipment/area.
- To Ensure Prior intimation to validation team regarding any qualification, requalification of area, equipment, and facility.
- To Ensure the Process flow, Personnel flow; Material flow shall be done as per the pre-defined procedures.
- Preparation and review of SOPs, and review of Batch records and process-related protocols.
- To perform/ensure the cleaning of items, equipment, and machine parts as per the SOP.
- Information to Immediate Supervisor in case any anomalies found in the machine/area.
- Close monitoring of the completion of batch Compounding.
- Batch Planning and manpower management as per the requirement.
- To ensure the online completion of batch records and logbooks and completion of batch transactions through ERP.
- Maintaining the minimum inventory of cleanroom consumables, items, and spares of equipments.
- Follow the fogging procedure as per SOP.
- Compounding and Filtration of Bulk solution as per SOP.
- CIP / SIP of Transfer lines, compounding vessels as per SOP.
- Operation of Filter Integrity Testing Machine.
- Integrity testing of Hydrophilic and Hydrophobic filters as per SOP.
- Initiation, review, and timely closure of all QMS elements like Change control, PNC, Exceptions, and CAPA as per procedure.
- Attending trainings like on job, cGMP, External, and Giving training on process-related SOP’s.
- Updating cGMP related practices and recent regulatory up-gradation to the personnel working on the shop floor to improve the systems.
- Co-ordination with the training team and ensures the completion of training of all the production personnel working in respective areas.
- Following safety systems and GMP systems during the work execution.
- To perform airflow visualization study (smoke study) as per approved protocol/sop.
- Any other job assigned by the Reporting Head.