Website:
inkarp.co.in
Job details:
Job Description
Position: Validation Executive
Location: Hyderabad
Experience: 2–3 Years
Qualification: B.Pharm / M.Pharm / MSc (Chemistry / Analytical Chemistry) / B.Tech (Biotechnology)
Job Overview
We are seeking a detail-oriented and technically sound Validation Executive to join our team as a central resource for qualification and validation documentation. The role will primarily focus on the
preparation of IQ/OQ documents and calibration certificates for a wide range of analytical and general laboratory instruments supplied to pharmaceutical, biotech, and quality control laboratories across India.
This position plays a critical role in meeting regulatory expectations and supporting our customers’ compliance requirements.
Key Responsibilities
- Prepare, review, and compile Design Qualification (DQ) and Installation Qualification (IQ) and Operational Qualification (OQ) protocols and final reports for various laboratory instruments (HPLC, GC, UV-Vis, FTIR, Dissolution Testers, Balances, pH meters, KF Titrators, Centrifuges, Incubators, Ovens, Rotary Evaporators, Stirrers, etc.).
- Prepare accurate and compliant Calibration Certificates for laboratory instruments as per ISO standards and customer-specific requirements.
- Maintain and update master templates of IQ/OQ documents for different brands and models of instruments.
- Coordinate with suppliers, principals, and internal technical teams to gather necessary technical data, drawings, and specifications required for qualification documents.
- Ensure all qualification and calibration documents meet current regulatory guidelines (cGMP, ICH, USP, ISO 17025, and 21 CFR Part 11 where applicable).
- Support customers during IQ/OQ execution and provide necessary documentation support during audits.
- Assist in Performance Qualification (PQ) protocol preparation and execution whenever required.
- Maintain proper documentation, version control, and archival of all qualification and calibration records.
- Stay updated with current regulatory trends and best practices related to equipment qualification and validation.
Experience
- 2 to 3 years of relevant experience in QA / Validation department of a Pharmaceutical company (formulation or API preferred).
- Hands-on experience in preparation of IQ, OQ, and calibration-related documentation for laboratory instruments or manufacturing equipment.
- Experience in a lab instrument distribution or service company will be an added advantage.
Skills & Competencies
- Strong understanding of equipment qualification (IQ/OQ/PQ) and validation principles.
- Excellent technical writing and documentation skills in English.
- Good knowledge of cGMP, ICH guidelines, and regulatory requirements for laboratory equipment.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Attention to detail and ability to work independently with minimal supervision.
- Good interpersonal and coordination skills to work with multiple internal and external stakeholders.
- Basic knowledge of analytical instruments (HPLC, GC, UV, etc.) will be preferred.
What We Offer
- Opportunity to work with leading international and Indian brands of laboratory instruments.
- Exposure to a wide range of analytical instruments and validation documentation.
- Professional growth in the field of validation and technical documentation.
- Collaborative and growth-oriented work environment.
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To Apply: Please send your CV to recruit@inkarp.co.in
Click on Apply to know more.