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Sr Project Eng / Senior Executive (Validation & GMP) in MNC at Delhi

9.00 to 14.00 Years   Delhi   08 Mar, 2021
Sharp Point HR Consulting
Job LocationDelhi
EducationNot Mentioned
SalaryRs 6 Lakh/Yr
IndustryRetail
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Roles and Responsibilities :* Comprehensive understanding of complete validation life cycle, risk based qualification methodology

  • Experience in pharmaceutical OSD facility / Sterile facility or both is preferred
  • Excellent knowledge of process equipment, utilities, HVAC and laboratory analytical instruments
  • Experience in authoring and review of all Qualification documents as per USFDA / Annex- guidelines
  • Excellent knowledge of cGMP standards and relevant EU/FDA regulations
  • Complete ownership of full validation cycle process implementation and associated documentation
  • Understanding of computer system validation as per GAMP 5 and CFR part 11 regulations
Major Job Responsibilities:
  • Preparation of validation master plans / qualification plans
  • Responsibility for the preparation of validation protocols e.g. Risk assessment, Design Qualification,
  • Installation Qualification, Operational Qualifications, Performance Qualifications, FAT / SAT etc.
  • Responsibility for the preparation of validation protocols for pharmaceutical process equipment, utilities,
  • HVAC and laboratory analytical instruments
  • Co-ordination with other project departments for the execution of validation projects
  • Co-ordination with clients to receive approvals during the project phases keeping a closed link to project management
  • Onsite execution of validation protocols, report generation / onsite qualification or commissioning activities
Desired Candidate Profile :Location: New Delhi ( However willing to travel to site for projects for extended durations.)Qualification: B. Pharma / M. Pharma / B.Tech / M.Sc. Life SciencesMinimum Experience: Min. 10 years or more Gender: MaleJob Category : This is a project based contractual position for 16-20 Months starting from May 2021. Project location is Bangkok - Thailand. Upon successful completion of project candidate might be offered a permanent position in Company. New Delhi.Perks and Benefits :Salary Range: Depending upon candidates knowledge and experience Interested. Kindly send us your updated CV on sunita@sharppoint.in with below mention details.Current & Expected CTC and Notice PeriodKindly refer your friends / colleagues who are looking out for job change.Regards,Sunita Prasad ,

Keyskills :
customer servicedeliveryreport generationprocess equipmentcfrmishvaccgmpsalesctcosdvalidation master planslife cyclecustomer relationscomputer system validationprocess implementationsatriskrisk assessment

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