Dr.Reddy’s – Walk-Ins on 18th Sept 2022 for PROCESS ENGINEERING – INJECTABLES / MSAT INJECTABLES

Dr. Reddy€™s Laboratories Ltd. (NYSE: RDY) 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. Reddy€™s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, 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

Vacancy Details

PROCESS ENGINEERING – INJECTABLES

Education: B.Tech / B.E / B.Pharma / M.Pharma
Experience: 03 to 08 year
Job location: HYDERABAD

Roles and Responsibilities

Delivery responsibility for the inhalation/injectable and  other suit of products by combining  formulation development and process understanding, working closely with the Development & Manufacturing Teams. Ability to effectively coordinate with manufacturing team to ensure plant readiness for given products and execution of trials/CB/EBs.

Exhibit decent expertise in inhalation/injectable dosage form, in the areas of QbD and process development to understand the developed process at POC scale.  Demonstrate knowledge of material characteristics and impact on stability, and manufacturability to design experiments for validation of assumptions for selection of prototype formulations. Abreast with formulaton development, scale up, advanced data analysis, PAT based control strategies.

Providing necessary technical inputs during interaction with R&D scientists for process robustness w.r.t. scalability, operability and cost effectiveness; Involving in process optimization with focus on right CPPs, CQAs and CMAs across scale. Interface with  Development and Plant Execution teams, to facilitate translation of engineering principles to execution and leverage their expertise for robust manufacturing process across scales.

Preparation of tech transfer documents ;Preparation of Safety Documents ; Preparation of gate meeting presentations; BPR Preparation and review; Review of Trial and validation documents(Trial protocol, Validation protocol, Trial report, Validation report) in-line with the project timelines; SBP technical evaluation for project suitability

Ensuring facility preparedness at plant for batch execution against the proposed modifications; Batch monitoring in coordination with CFT teams; Ensuring successful execution of plant batches as per requirements; Trouble shooting of any process related issues at plant; Monitoring project related experiments at Vendor sites [FAT, SAT etc.]

Date: 18th Sept 2022
Time: 9.30 AM – 2.00PM
Venue: Pride Plaza Hotel Ahmedabad, Judges Bunglow Road, S.G. Road, Bodakdev, Ahmedabad 380054, Gujarat, India.

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MSAT INJECTABLES

Education: B.Pharma / M.Pharma
Experience: 03 to 08 year
Job location: Visakhapatnam

JOB DESCRIPTION:

• Reviews and follows safety requirements with respect to process.
• Reviews and follows safety requirements with respect to equipment.
• Reviews and follows safety requirements in handling materials.
• Reviews unit operations, various processes, Process and cleaning validation.
• Reviews technical assessments and provide support to execute product trials, CBs & EBs.
• Demonstrates basic understanding of regulatory requirements related to technology transfer, cGMP & Sterility strategies.
• Reviews process OOS/OOT and defines appropriate CAPAs.
• Reviews unit operations, various processes, Process and cleaning validation.
• Reviews written procedures (SOPs) & basic GMP requirements.
• Reviews procedures related to NPIs/Process validation/Cleaning validation etc.
• Understands, follows and executes Good Documentation Practices and ensures contemporaneous entries.
• Reviews and provides support for process validation and cleaning validation program.
• Reviews and provides technical support to process improvement initiatives.
• Reviews and provides technical support in the scaleup of commerical / new products.
• Reviews and Provides technical support in evaluating CPPs, CQAs and maintain product robustness throughout product life cycle.
• Understands, Review process steps and take the process data from MES/PASX .
• Understand business processes with system and can prepare validation documentation.

Date: 18th September 2022
Time: 9.30 AM – 2.00 PM
Venue: Pride Plaza Hotel, Ahmedabad . Judges Bungalow road, SG road, Bodakdev, Ahmedabad 380054, Gujarat, India