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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

- 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 robust interpersonal skills.
- Positive communication skills in English.

GENERAL

- Candidates to send resumes with photograph.

📌 Validation & Qualification / Gmp (Delhi)
🏢 RECEX
📍 Delhi