09 Oct
|
Kalyan Business Solutions.
|
Kala Amb
09 Oct
Kalyan Business Solutions.
Kala Amb
Job Summary
We are looking for our client an experienced and detail-oriented Quality Executive – Validation to join our Quality Assurance team at Kala Amb, Haryana. The ideal candidate should have 4–6 years of relevant experience in pharmaceutical validation and quality assurance, with a strong understanding of validation protocols, documentation, GMP requirements, and regulatory compliance.
The candidate will be responsible for planning, executing, reviewing, and documenting validation activities to ensure that manufacturing processes, equipment, systems, and procedures consistently meet established quality and regulatory requirements.
Key ResponsibilitiesValidation Activities
- Plan, coordinate, and execute validation activities in accordance with approved protocols and procedures.
- Handle process validation, cleaning validation, equipment qualification, and related validation activities.
- Prepare, review, and execute validation protocols and reports.
- Ensure proper documentation of validation activities and maintain validation records.
- Monitor validation activities to ensure compliance with approved procedures and timelines.
- Review validation data, results, deviations, and observations.
- Coordinate with Production, QC, Engineering, and other departments during validation exercises.
Quality Assurance & Compliance
- Ensure validation activities comply with GMP, SOPs, regulatory requirements, and company quality standards.
- Review and assess deviations, discrepancies, and out-of-specification results associated with validation activities.
- Support investigations and implementation of appropriate CAPA wherever required.
- Participate in internal audits, regulatory inspections, and customer audits related to validation activities.
- Ensure timely completion and closure of validation-related documentation.
Documentation
- Prepare and maintain validation protocols, reports, qualification documents, and supporting records.
- Review SOPs, specifications, risk assessments, and other quality documents related to validation.
- Maintain the Validation Master Plan (VMP) and validation schedule, where applicable.
- Ensure proper data integrity and traceability of validation records.
Required Qualifications
Candidates with any of the following qualifications are eligible:
- M. Pharma
- B. Pharma
- M.Sc.
- B.Sc.
Required Experience & Skills
- 4–6 years of relevant experience in pharmaceutical Quality Assurance/Validation.
- Strong practical knowledge of process validation, cleaning validation, equipment qualification, and validation documentation.
- Valuable understanding of GMP, SOPs, CAPA, deviation management, and quality systems.
- Knowledge of regulatory expectations and pharmaceutical quality standards.
- Strong documentation and analytical skills.
- Good communication and cross-functional coordination abilities.
- Ability to independently manage validation activities and meet timelines.
- Strong attention to detail and commitment to quality.
Pay: ₹35,000.00 - ₹40,000.00 per month
Work Location: In person
📌 Quality Executive (Kala Amb)
🏢 Kalyan Business Solutions.
📍 Kala Amb