HomeProductionSr Executive - Formulation Manufacturing | Syngene International (Biocon) | Bengaluru

Sr Executive – Formulation Manufacturing | Syngene International (Biocon) | Bengaluru

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Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries around the world.

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Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Position: Senior Executive  – Formulation Manufacturing

Location: Bangalore, Karnataka, India

Job Description:

Job Purpose

  • Responsible for supervision of solid oral dosage Manufacturing activities as per production plan, safety, documentation, and compliance for the facility.

Key Responsibilities:

  • Documentation Management for Preparation, Review & Approval of the SOP’s, EOPs, IOPs. Area monitoring etc both manually and in an electronic document management system (EDMS) as an author and coordinator.
  • Document management for Preparation, Review, approval of URS, DQ, IQ, OQ and, PQ of equipment/ instruments, etc both manually and in the electronic document management system (EDMS) as an author and coordinator.
  • Support for FAT, evaluation of equipment risk assessment, Assist in protocol preparation for Decommissioning of existing equipment’s and commissioning from at new facility.

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    Support for entire plant Area validations, Qualification to meet projected timelines.

     

  • Support in building, Implementation, and following of cGMP requirements at all stages to meet compliance w.r.t. USFDA, EU, MHRA standards.

     

  • Support in facility planning to achieve weekly, monthly targets, capacity utilization, monitor and up keeping for the smooth functioning of production activities, clinical batches manufacturing/commercial batches manufacturing.

     

  • Monitoring and maintenance of equipment’s logbooks

     

  • Purified water plant management and ensure the smooth functioning of the water system.

     

  • Training to Technicians on New equipment and instruments during installation.

     

  • Support and coordination with various cross functional teams to meet project timelines.

     

  • Raising indent for new instruments /equipment’s/ new accessories for day to day functioning of the formulation development center.
  • Work allocation to technicians in the formulation development center.

     

  • To monitor, control, and handle of tooling and change parts for all equipment’s in the Development lab and OSD pilot plant.

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    To ensure the implementation of the EHS policy.

     

  • Support in preparation of various client visits, regulatory and QP audits.

     

  • Management of QMS documentation like change controls, incidents, deviations – investigations, CAPA, etc both manually and in electronic Quality management sy stem (EQMS).

     

  • Training of SOP, EOP, and IOP to all employee-related to formulation production.

     

  • Support inline management (cleaning, storage, and inventory of garments).

     

  • Ensures that the new employee has indicated their signature in the specimen signature logbook on or prior to sign off the job description.

     

  • Identifies the training needs in consultation with Department Head for employees initially and whenever there is a change in job roles and responsibilities of employees.

     

  • Prepares a training matrix as per the defined job roles for the new entrant.

     

  • Ensures that the training needs of all employees in the department are completed.

     

  • Archiving of training records of respective departmental employees.

     

  • Ensures training records of resigned employees are stamped as per the procedure.

     

  • Uploading of content in LMS and mapping of cross-functional procedures to users.

     

  • Identifying and maintaining the training records of all the approved service providers.

     

  • Filing of any evaluated questionnaires in respective training records.

     

  • Ensures training files are reviewed and certified by the concerned Quality Assurance after training completion.

     

  • Tracking of completion of training for the identified employees in LMS

     

  • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety

     

  • Attend training on environment, health, and safety (EHS) measures imparted company

Technical/Functional Skills:

  • Experience in solid oral dosage manufacturing facility. Granulation, compression, coating, and packaging
  • Experience in parenteral or semi-solid manufacturing facilities would be an added advantage.

Behavioral Skills:

  •  Should have the capability to work in a team and the ability to handle demonstrate a good team spirit.
  • While possessing a good ability to follow instructions should also demonstrate innovation in his/her approach, good communication skills.
  • Should be proactive while working on allotted responsibility.

Qualification: B.Pharma

Experience: 3-6 Years

Salary: Negotiable

Contact Details:

careers@syngeneintl.com

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