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
- 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.
Experience: 3-5 Years of Relevant Experience
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