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Urgent Opening for QC Manager

6.00 to 11.00 Years   Mumbai City   25 Apr, 2019
Sevalal Enterprises Hiring For Sevalal Enterprises
Job LocationMumbai City
EducationNot Mentioned
SalaryRs 5 - 12 Lakh/Yr
Industryharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

Dear Sir,we have Vacancy For QC Department in Tarapur ( Boisar Location)Post: Executive / MANAGERExperience Required - 5 to 15 YearsCompany - API PLANT USFDA APPROVED (Pharma)JD:

  • Analytical Method validation for drug substance(API) as per ICH guideline.
  • Review of Analytical Method validation raw data, protocol and report.
  • Responsible of preparation of method validation report.
  • Responsible handling of technology transfer with preparation of protocol and report of QC and AMV Dept.
  • Responsible for handling of impurity and working standard department.
  • Responsible for handling of deviation of ADL and QC department.
  • Responsible for handling ofevent,labincident report of ADL and QC department.
  • Responsible handling of out of Specification result investigation and documentation.
Responsible
  • Responsible for preparation of stability protocol and report.
  • Responsible for preparation and reviewof Specifications,Testing procedure of finished product,Raw materials,intermediate .
  • Responsible for handling and planning of internal, GLP, GMP training.
  • Responsible for review of audit trail and electronic data.
  • Responsible for review of Internal Calibration of Equipments as per frequency mentioned in SOP and coordination with maintenance for external calibration as per SOP.
  • Responsible for daily review all utilized instrument usage logbook.
  • Responsible for review of raw material, in-process, intermediate, finished Product and stability study raw data sheet.
  • Preparation and Review of General,Operation and Calibration Standard Operating Procedure(SOP) and raise change control as per requirement.
  • Responsible for Stability study of drug substance as per ICH guideline.
  • Responsible for for Analysis of drug substance(API) routine analysis.
  • Responsible for analysis of raw material, in-process, intermediate routine analysis.
INSTRUMENTS HANDLED:
  • HPLC System:
Water Alliance with Empower 3 Software,Dionexwith Chromeleon 6.8 version Software,Shimadzu (LC-CHT2010) with Empower 3 Software,Agilent (1200, 1100 Series) with Open Lab Software.
  • GC System
Chemito with C2000 Software
  • UV/VIS System :
Shimadzu (1700) & 1800 UV Probe softwareJasco (V-630) with Spectra Manger software
  • Polarimeter :
Jasco (P-2000) with Spectra Manger software.
  • PH Meter ( DBK,Lab India Pico+)
  • Karl Fisher Apparatus (Make: Veggo,Lab India-Titra)
  • Melting point apparatus (VeegoMaticD,Lab India- KAFI)
  • Auto Titrator (Lab India Titra)
  • Analytical Balance (Shimadzu AUW220D) with printer.
Best Regards,Miss. Seema PatelContact : 8793920777/ 9561260777H.R & Admin.SEVALAL JOB PLACEMENTE/002 Ground Floor, Krisha Apt. Buldg No.-10, Yashwant Srushti, Back Side Sai Baba Temple, Boisar Palghar Road, Boisar (W).8087652777/8983655777/8983920777

Keyskills :
hplcsystemateralliancewithempower3softwarephmeter

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