Company DescriptionDr. Reddys 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 Cant 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 transparencyDr Reddys 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.Roles & ResponsibilitiesDocumentation:
Preparation / Review of functional standard operating procedures.Preparation of MFR and PORM.Preparation of Submission Batch /Pre -validation Protocols and reports.Preparation of Hold time protocols and reports.
Preparation of confirmatory/Trial batch Protocols and reports.
Follow ups with the cross functional team (CFT) for review corrections and
approvals.Follow up for BOM and Recipe approvals.Creation of Bill of Materials and Recipes in SAP.
Modification of Bill of Materials and Recipes.Master Batch Records Activify in PAS-X for manufacturing:
Designing of MBR's based on the CB report, Product Information Sheet, & PORM
for new products as well as site transfer products.
Designing MBR as per process, formulations and PAS-X system required.
Dcsigning MBR's by fallowing the standard operating procedures and GMP
requirements.
Manufacturing order (MO) creation in PAS-X Quality server.
lntcraction with Production, Ware house and designing MBR as per requirement for
creating efficient MBR's.
Follow ups with CFT's and PAS-X administrator resolving issue relatcd to MBR
Creation of MBR Libraries considering the product process requirement and
parameterization.
ldentification of problem during real time execution of batches and rectification of
MBR related issues.
Participation in Organizational events, pcrsonality dcvelopment program and other
initlativcs.Master batch records Activity in PAS-X for packing
o Designing of GBMR, PVL, PMBR & MBR based on the MPC / Data sheet for new
products as well as site transfer products.
o Manufacturing order (MO) creation in PAS-X Quality server
o Interaction with Production, Ware house and designing of packing MBR as per
requirement for creating efficient MBR's.
o Follow ups with CFT's and PAS-X administrator resolving issue related to
GMBR,PVL,PMBR & MBRQualificationsEducational qualification: Bachelor's in PharmaMinimum work experience: 3-5 years of experience, preferably in documentation in a manufacturing environmentSkills & Attributes
Technical Skills
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