Reputed Pharma Company Hiring – QA (CSV & Cleaning Validation)
A Reputed Pharmaceutical Company in Indore, Madhya Pradesh is inviting applications from experienced professionals for the QA Department. Candidates with 6–10 years of experience in Computer System Validation (CSV) and Cleaning Validation in the pharmaceutical industry are encouraged to apply.
Reputed Pharma Company
Quality Assurance (QA)
Indore, Madhya Pradesh
6–10 Years
B.Pharm / M.Pharm / Life Science
Pharmaceutical Manufacturing
Job Responsibilities – QA (CSV & Cleaning Validation)
The selected candidate will be responsible for Computer System Validation (CSV), Cleaning Validation, and GMP compliance activities in the Quality Assurance department.
Computer System Validation (CSV)
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Prepare and review Validation Master Plan (VMP), URS, FS, DS, IQ, OQ, PQ, and validation reports.
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Execute Computer System Validation activities for GxP software and computerized systems.
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Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity requirements.
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Perform risk assessment, change control, periodic review, and system lifecycle documentation.
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Coordinate with QA, IT, Engineering, Production, and vendors during validation activities.
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Maintain validation documents and audit-ready records.
Cleaning Validation
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Prepare Cleaning Validation Protocols and Reports for manufacturing equipment.
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Perform cleaning validation studies for formulation manufacturing processes.
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Review sampling plans, recovery studies, and acceptance criteria.
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Ensure compliance with cGMP, regulatory guidelines, and SOPs.
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Investigate cleaning validation deviations and CAPA implementation.
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Support qualification and revalidation activities for equipment and cleaning processes.
Quality Assurance Responsibilities
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Ensure compliance with cGMP and pharmaceutical quality systems.
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Participate in internal audits, regulatory inspections, and documentation review.
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Review SOPs, protocols, reports, and validation documentation.
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Support continuous improvement initiatives in validation and quality systems.
Candidate Profile
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6–10 years of experience in QA – Computer System Validation (CSV) and Cleaning Validation.
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Experience in formulation pharmaceutical manufacturing is preferred.
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Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, GMP, and Data Integrity.
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Experience in validation documentation, risk assessment, and change control.
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Good communication and documentation skills.
How to Apply
Apply Now
Interested candidates can contact:
Rajesh Kumar
Bright Future Consultancy, Chandigarh
8780446962
