Production Documentation Team Member at Dr. Reddy’s Labs, Apply Now!

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry

evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable.  Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job Summary

We are seeking a dynamic and experienced Production Documentation in Active Pharmaceutical Ingredient (API) to support the development of robust and cost effective API’s by timely supporting of the all GMP  documentation activities for scale up batches for all new and existing APIs at GMP Kilo Lab.

Roles & Responsibilities

• Documentation Responsibilities:
• You will be responsible for Initiation of change notification based on the requirement of the production for revising the SOPs, Batch production records (BPR), equipment cleaning records (ECR), Protocols (Process and Cleaning), Process flow, Process description, Reports and quality equivalence reports.
• You will be responsible for Timely updating the production SOPs, and associated forms.
•  You will be responsible for Support or preparation/review of viable monitoring trends based on requirement
• You will be responsible for Initiation and closure of change notification and action items as per production requirements
• You will be responsible for Preparation for investigation reports/product failure/deviations and take necessary corrections, corrective actions and preventive actions by co coordinating with QA & other CFT team like R&D/QC etc.
• You will be responsible for Preparation of URS, Impact assessment for new equipment’s.
• You will be responsible for Preparation of process validation protocols/Batch execution protocol/trial protocol, BPRs and related documents.
• You will be responsible for Preparation of cleaning protocols, Equipment Cleaning Records & reports.
• You will be responsible for Preparing the Quality and Yield equivalence reports.
• You will be responsible for Preparation of General study protocols, reports, Production consumable assessments and PR initiation for production consumables etc.
• You will be responsible for Creating awareness to the shop-floor people and reports.
•  You will be responsible for Attending to the cGMP / SOP / other training sessions as per requirement to update the knowledge and meet the compliance standards.
• You will be responsible for Actively participate in all the Internal & Regulatory Audits
• You will be responsible for Timely respond to all the observations from audits, QA Observations, Gemba walks and ensure to close all the points as per the time lines.
• You will be responsible for Ensure the completion of preventive maintenance/calibration in coordination with ESD.
• You will be responsible for Providing training to production/CFT team for Protocol/BPR etc as per change control action points.

Educational qualification: B.Sc, M.Sc Chemistry, Diploma in Chemical engineering

Minimum work experience: 2-10 years of experience in Pharma industry with documentation experience

Skills & attributes:

Technical Skills

• Experience on API Process & Procedures
• Knowledge in API chemical Process & equipment.
• Knowledge of unit operations.
• Knowledge in all digital tools like Docuhub, Docusign and MS office/ MS word/MS excel etc
• Experience in data entry in SAP system.

Behavioural Skills 

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.