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Executive - Formulation Development

6.00 to 8.00 Years   Mumbai City   26 Oct, 2022
Galentic Pharma (India) Pvt Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    Job position: Executive / Senior Executive - Formulation DevelopmentDepartment: Formulation Development - R&DQualification: PhD/M.PharmExperience: 6 to 8 years (Semi solid dosage)Job responsibilities:
    1. Responsible for generic and NDA formulation development of sterile ophthalmic and non-sterile dermatological products for regulated and non-regulated markets.
    1. Conduct literature search, patent evaluation and preparation of literature report.
    1. Preparation and/or review of documents such as formulation development approach paper, stability protocol and report, drug-excipient study protocol and report, bill of material, master formula card, batch manufacturing record, product development report, SOP, format, CoA, etc.
    1. Pre-formulation studies including API and innovator product characterization, etc.
    1. Procurement of API, raw material and packaging material for development batches.
    1. Manufacturing of lab scale batches and evaluation of in-process, finished product and stability samples.
    1. Conduct formula and process optimization studies.
    1. Execution of technology transfer and monitoring of scale-up, pilot, trial/engineering, exhibit/ registration batches and validation activities at plant.
    1. Must have knowledge and expertise in aseptic area and handling of machinery/equipment related to topical dosage forms.
    1. Issuance, maintenance, writing, review of raw data, completeness check and archival of laboratory notebook.
    1. Review and/or approve documents and provide technical support to Rabale and Kandla production team during technology transfer and/or validation whenever applicable.
    1. Routine calibration and qualification of laboratory instruments and equipment.
    1. Training coordinator for new joinee in Formulation Development team.
    1. Provide training and guidance to junior scientists in formulation development.
    1. Perform installation and qualification procedure for instruments and equipment along with calibration of all instruments and equipment as required.
    1. Co-ordination with service engineers for instrument and equipment calibration, maintenance and trouble shooting.
    1. Support GDP, GLP, internal and external audit and compliance related activities within department to be in-line with QMS and USFDA requirement.
    1. Follow strict adherence to Good Documentation Practices and Good Laboratory Practices.
    1. Co-ordinate and interact with Analytical Development, QA, Purchase, Procurement, Regulatory Affairs, Production, QC, etc. for smooth execution of various projects.
    1. Assess requirement for new instrument/equipment, prepare URS, obtain comparative data, and monitor installation and qualification procedure.
    1. Maintenance of Formulation lab functionality as per requirement.
    1. Candidates with hands-on experience in QbD and DoE preferred.
    1. Must have good communication, writing and inter-personal skills.
    1. Effective planning, quality execution and organization of work is a must.
    1. Any other duties as per organizational requirements.
    Interested candidates apply at hidden_email

Keyskills :
sterilendaformulation developmenttechnology transfernon sterile

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