Validation & Qualification / Gmp

3 weeks ago

Delhi, India RECEX Full time

DISCIPLINE DEPARTMENT VALIDATION QUALIFICATION GMP POSITION EXECUTIVE FEMALE CANDIDATE ONLY EXPERIENCE REQUIRED MIN 2-6 YEARS CTC DEPENDING UPON CANDIDATES KNOWLEDGE AND EXPERIENCE QUALIFICATION B PHARMA M PHARMA M SC LIFE SCIENCESJOB DESCRIPTION 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 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 reports 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 COMPETENCIES Must have good communication skills Must have the ability to work independently while meeting the project schedules Team player Willing to travel to client sites EDUCATIONS QUALIFICATIONS B Pharma M Pharma M Sc Life Sciences EXPERIENCE BRACKET 2 to 6 years of experience in Validation Qualification and Documentation in the Pharma Biotech Medical Device Industry SKILL SETS Strong Leadership skills Decision making Conflict management and strong interpersonal skills Good communication skills in English GENERAL Candidates to send resumes with photograph

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