Team Member-Production Documentation

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 APIs 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 equipments.
• 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 shopfloor 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.

Qualifications :

Educational qualification:  Chemistry Diploma in Chemical engineering

Minimum work experience: 210 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 problemsolving abilities.
• Ability to work collaboratively with own team and crossfunctional teams. 

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cuttingedge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven innovationfocused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at

Remote Work :

No

Employment Type :

Fulltime