Job Description

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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