Handling production manufacturing area.
Role & responsibilities Preparation and review of Validation master plan Handling of qualification and Validation related activities. Qualification of new equipments at site and preparation of DQ, IQ, OQ and PQ. Responsible for communicating with approved outside laboratories to perform all validations as per validation master plan. Responsible for review of outside laboratories reports. Responsible for review routine validation of all validations like HVAC Validation, cartridge filter validation, CIP/ SIP validation, autoclave validation etc. Preferred candidate profile Handling of final release of batch of finished product through ERP. Implementation of Good documentation Practices Preparation and Compilation of Protocol and Report. Active participation in Internal Audits and Vendor Audit. Preparation and Review of Sops. Of concerned Department. Review of environmental monitoring records of all areas. Handling of QMS activities. Handling of artwork. Preparation of new BOM in ERP. Issuance of monthly formats and log books. Retrieval of final batch records from production department. Maintaining the control sample records. To check the environmental condition of respective area and fill the formats Updation of MRP list. Review of Finished COA Final batch record and COA data entry in to APQR. Preparation of Water trend of each stage. Issuance of BMR and BPR. Involve in all IPQA activities. Review of batch records and finally check the reconciliation of yield of batch. Temperature, RH, and Differential pressure monitoring in control area. Updation of related log book and formats of related area.
Role & responsibilities Conduct pre-formulation and formulation development of new pharmaceutical dosage forms (solid, liquid, semisolid, etc.). Perform compatibility studies for Drug-Excipient interactions. Design and execute laboratory-scale and pilot-scale trials . Develop and optimize manufacturing processes , ensuring scalability and reproducibility. Maintain batch manufacturing records (BMRs) and development reports . Support analytical development teams with stability and validation studies. Assist in technology transfer to production and contract manufacturing sites. Ensure adherence to GMP, GLP, and regulatory guidelines (e.g., USFDA, MHRA, WHO). Collaborate with cross-functional teams: QA, QC, Regulatory Affairs, and Production. Troubleshoot formulation and process-related issues. Participate in product lifecycle management and cost optimization initiatives. Preferred candidate profile Strong knowledge of formulation principles and pharmaceutical excipients . Experience in process optimization and scale-up . Familiarity with equipment like granulators, tablet presses, blenders, etc. Attention to detail and documentation accuracy . Good communication, problem-solving, and team collaboration skills.
Role & responsibilities Conduct pre-formulation and formulation development of new pharmaceutical dosage forms (solid, liquid, semisolid, etc.). Perform compatibility studies for Drug-Excipient interactions. Design and execute laboratory-scale and pilot-scale trials . Develop and optimize manufacturing processes , ensuring scalability and reproducibility. Maintain batch manufacturing records (BMRs) and development reports . Support analytical development teams with stability and validation studies. Assist in technology transfer to production and contract manufacturing sites. Ensure adherence to GMP, GLP, and regulatory guidelines (e.g., USFDA, MHRA, WHO). Collaborate with cross-functional teams: QA, QC, Regulatory Affairs, and Production. Troubleshoot formulation and process-related issues. Participate in product lifecycle management and cost optimization initiatives. Preferred candidate profile Strong knowledge of formulation principles and pharmaceutical excipients . Experience in process optimization and scale-up . Familiarity with equipment like granulators, tablet presses, blenders, etc. Attention to detail and documentation accuracy . Good communication, problem-solving, and team collaboration skills.
Execution of Development batches. Execution of pre-formulations studies,drug-excipients compatibilities studies & literature. Design and evaluation formulation trials to develop optimize formula. ' Preparation of documents like PDR, MFR,Q&Q.BMR,PVP,PVR,Compatibility protocols and stability protocols, Preparations and management of stability batches. Evaluation and reverse engineering of innovator/refer.ence products. Preparation of technical package of documents fbr DCGI and DCA. Preparations and managenrent of stability batches. Execution ofscale-up and exhibit batches. Execution of technology transfer products and commercial production troubleshooting. A Coordination with others departments like AR&D,QA,RA,production,QC,packaging and vendors to complete projects within timeline.Role & responsibilities