Dr. Reddys Laboratories Ltd. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products Dr. Reddys offer a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, and differentiated formulations.

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   The major therapeutic focus is on gastrointestinal, cardiovascular, diabetology, oncology, pain management, and anti-infective. Major markets include India, USA, Russia-CIS, and Europe apart from other select geographies within Emerging Markets. For more information, log on to www.drreddys.com

Position: Team Member IPQA ( Formulations)

Location: Pydibheemavaram, Vizianagaram, Visakhapatnam

Job Description:

  • Overall responsibility for line clearance, material verification, starts up checks, and in-process checks as per the Batch manufacturing and Batch packing records.
  • Review and Approval of masterbatch records /batch packing records and certification of the same after execution.

     

  • Review of executed batch records /batch packing records and ensuring reconciliation of product at each stage of production activity.

     

  • Collection of In-process samples, Reserve sample, Bulk samples, finished samples, and stability of samples for analysis as per protocols/BMR’s/BPR’s.

     

  • Review and approval of process validation protocols& reports.

     

  • Review and approval of Hold time study protocols & reports.

     

  • Ensuring the training of all operators and workers who are working in the manufacturing area & packing area.

     

  • Reserve sample collection, maintenance, and inspection and destruction of expired samples.

     

  • Monitoring of process simulations, review & approval of media fill protocols & reports

     

  • Ensure pest & rodent control activities are carried out as per SOP.

     

  • Ensure the availability of standard operating procedures in the SOP stand provided for all areas.

     

  • Review & approval of operating instructions / standard cleaning procedures / standard operating procedures & any other master documents.

     

  • Check & ensuring the calibration status of instruction, validation/revalidation/preventive maintenance of the equipment.

     

  • Handling of quality notifications.

     

  • Coordination in cleaning validation, sampling, completion, and compliance.

     

  • Monitoring of personal hygiene of all employees.

     

  • Ensuring good manufacturing & documentation practices.

     

  • Support/review & Investigation of market complaints, product recall, genuineness of verification in case of a counterfeit complaint from RA.

     

  • Verification of rejected batches & expired raw materials in the warehouse for disposal.

     

  • Implementation & compliance of technology transfer & initiation of exhibit batches.

     

  • Coordination in sampling, dispensing activities, and return of dispensed materials to warehouse.

     

  • Coordination to identify the impact on system/procedures due to new product inclusion at the plant and shall propose to update SMF, VMP, product list, equipment’s cleaning matrix & other related documents.

     

  • Responsible to carry out the Pack Stock Check and to report the observations.

     

  • Responsible for monitoring of projects like facility/equipment after initiation of the technology transfer at the proposed manufacturing location.

     

  • Responsible for clearance of facility, equipment usage for the next product after verifying the Cleaning verification Data.

     

  • Review of all logbooks used in production, packing & warehouse area.

     

  • Issuance of BPR.

     

  • A timely sampling of In-process samples/reserve samples/stability samples.

     

  • Review of status online activity and its labeling in warehouse/production/engineering and utility areas.

     

  • Ensuring stability sampling as per Standard Operating Procedure / Protocols and its management as per system requirements.

     

  • Handling of building and facility maintenance plan.

     

  • To create the Password for an equipment corresponding user based on his access level.

Qualification: B.Pharma/M.Pharma

Experience: 3-5 Years of Relevant Experience

Salary: Negotiable

Contact Details:

talent@drreddys.com, nareshkumar.g@drreddys.com, schatterjee@drreddys.com

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