VALIDATION & QUALIFICATION / GMP

Job Description:

DISCIPLINE / DEPARTMENT VALIDATION & QUALIFICATION / GMP
POSITION EXECUTIVE (FEMALE CANDIDATE ONLY)
EXPERIENCE REQUIRED MIN. 2-6 YEARS
CTC DEPENDING UPON CANDIDATE’S KNOWLEDGE AND EXPERIENCE
QUALIFICATION B. PHARMA / M. PHARMA / M.SC. LIFE SCIENCES

JOB 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.