Encube Ethicals is an integrated pharmaceutical topical organization dedicated to only semisolid formulations since 23+ years. Our focus is to consistently excel in manufacturing and development of topical formulations which touches millions of patients globally. We help our customers serve global markets with innovative, technology driven & cost effective topical products of the highest quality.
Executive / Senior Executive (Quality Control)
Department : Quality Control
Section : Method Validation
Experience : 6 to 9 years in Analytical Method Development & Validation Section
Qualification : M.Sc/ M.Pharma
Location : Goa
Job Description
• Preparation of protocols related to method validation, method transfer and method verification activities.
• Knowledge and experience in Method development activities is essential.
• Managing and independently handling requirements of instruments in laboratory.
• Candidate should have bench level work exposure of analysis on various analytical instruments (HPLC, GC ond Dissolution) & Equipment's
• Review and compilation of reports of analytical method validation, method verification and method transfer. Responsible for execution of all analysis related to validation, verification and transfer activities.
• Good Documentation practices and maintenance of good GLP ecosystem in the regulatory laboratory and knowledge on 21 CFR Part 11 Compliance
Executive / Senior Executive (Quality Assurance)
Section : Lab QA
Experience : 6 to 9 years
Qualification : M.SC / B.Pharm / M.Pharm
Location : Goa
Job Description
• To apply, develop and maintain quality assurance practices which will enable the laboratory to meet and exceed the desired quality standards of regulatory.
• To review and investigate OOS, OOT, quality relevant incidents and non-conformance of laboratory and define appropriate CAPAs along with QC department.
• Good understanding and knowledge of Caliber LIMS and QAMS.
• Good knowledge on Empower and standalone system/ data audit trails.
• Engaging with customer to explain the investigations.
• Review of QC analytical reports for RM, PM, IP/FP & STB and instrument calibration records.
• Review of analytical method transfer, method validation protocol and report.
• Training on procedures, STP's as per the investigation flow.
• Issuance of investigation formats such as OOS, OOT, Incidence and raw data sheet.
• To review the lab incidences of quality control and guide QC colleagues towards the closure.
• Review and approval of stability chamber temperature and humidity data.
Note
• Male candidates will be preferred
• Candidate must be willing to work in all three shifts
Mail your resume on santoshi.n@encubeethicals.com / hrdesk@encubeethicals.com
Encube Ethicals Pvt. Ltd. C/l, Madkaim Industrial Estate, Madkaim, Ponda, Goa - 403404
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