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Career

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Our constant endeavor to search for new solutions fuels our company’s growth and diversification. We have a Research and Development Wing that spends countless hours to look for new innovate technologies and help us to maintain a competitive edge in the market.

Responsibilities

  • To perform analysis of Raw Materials, Intermediate/Finished Products.
  • To receive daily working schedule from Manager QC (O&C).
  • To inform Assistant Manager QC (O&C) about non-conforming results of Raw Material, Intermediate/Finished Products.
  • To complete and compile analytical record.
  • To conduct Sampling of raw materials.
  • To comply with Good Laboratory Practices (GLP).
  • To perform In-house calibration of Lab Instruments assigned by the Assistant Manager QC (Chemical Section).
  • To perform any special tasks related to his/her technical skill other than to routine work, if asked so by related authorities.
    • Responsibilities

  • To assure the GMP compliance in all respective assigned jobs as Officer QA (Validation).
  • To assist in the elaboration, implementation and maintenance of Site Validation Master Plan, and assure that the validation policy is being followed.
  • To participate in the preparation and reviewing of validation protocols and reports.
  • Follow up of the calibration program in liaison with the Engineering Department for all instruments in the plant
  • Handling all activities related to validation department.

  • To coordinate in lision with engineering and production department for the execution of all qualifications (DQ.IQ.OQ.PQ) activity.
  • Reviewing and assessing the impact of any changes in process or equipment on the corresponding validation status.
  • Provide technical support in resolving validation-related exceptions or deviations.
  • Provide validation-related technical assistance to all the departments
  • Provide validation support to plants for new projects assigned.
  • Training, developing and managing performance of staff related to the validation department.
  • Review/report Validation related metrics and undertake corrective measures regarding the compliance to the Validation policy in close coordination with Assistant Manager QA (O&C) and Deputy Manager QA (O&C)
    • Responsibilities

  • In process monitoring & overall GMP compliance of sterile area and packing operations.
  • For sterile filling check that only sterile vials and nozzles are used.
  • Check that the operators in the manufacturing &filling rooms are wearing specified uniform.
  • Checking of filling section for product name, batch number and QC released slip.
  • In process checking of filling volume of the filled vials and record the average results on volume control sheet after each 60 minutes.

  • Environmental monitoring (viable & non-viable) of sterile area, in liaison with Production and QC departments.
  • Checking of finished packs for carton’s general appearance, product name, batch number, manufacturing date, expiry date, price (if applicable) after each 60 minutes.
  • Checking of shippers for standard number of packing units, product name and batch number.
  • In process checking of redressed products as per requirement.
  • Record observations at each step on inspection sheet.
    • Job Description

  • Lab. scale preparation of new drug product as per the standard procedure.
  • Assisting the Assistant Manager New Product Development (IBD) in all issues that are related to the development of new drug products.
  • Country specific packaging material development for the new drugs and the revision of the existing export only products.
  • Generation of the supporting documents that are required by the IBD regulatory for the registration of drugs.
  • Monitoring of the stability studies of new drug products.
  • Monitoring of the overall cleanliness of the New Product Development Lab.
  • Performing any special tasks related to his/her technical skill other than routine work, if asked so by related authorities.
  • To ensure all the processes and operations are managed under the environment of current good manufacturing and laboratory practices.
  • Training of the RND staff on cGMP, GLP, DRAP and WHO guidelines.

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