Sr. Process Validation Specialist - Pharma
Royal Herbs
Employer Active
Posted 12 hrs ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
Key Responsibilities
- Process Validation
- Develop and execute Process Validation Master Plans (PVMP) and protocols for pharmaceutical and herbal products.
- Conduct process qualification and re-validation in alignment with regulatory and internal requirements.
- Evaluate critical process parameters (CPPs) and critical quality attributes (CQAs) to ensure consistent product quality.
- Coordinate with Production, QA, QC, and Engineering during validation activities.
- Review and analyze validation data, prepare summary reports, and recommend improvements where needed.
- Cleaning & Equipment Validation
- Plan and execute cleaning validation for equipment used in pharma and herbal product manufacturing.
- Ensure cleaning procedures are validated to prevent cross-contamination.
- Perform equipment qualification (IQ/OQ/PQ) and maintain proper documentation and traceability.
- Coordinate with Engineering and Production to ensure equipment readiness and calibration.
- Documentation & Compliance
- Prepare and maintain all validation-related documentation (protocols, reports, risk assessments, change controls).
- Ensure compliance with GMP, EDA, WHO, and ISO requirements.
- Participate in internal and external audits, presenting validation evidence and supporting documentation.
- Review deviations and implement CAPA related to validation processes.
- Continuous Improvement
- Support process optimization and continuous improvement initiatives through data-driven validation results.
- Recommend new validation tools, approaches, and risk-based methodologies.
- Train production and quality staff on validation awareness and GMP compliance.
Desired Candidate Profile
- Bachelor s degree in Pharmacy
- Minimum 3-5 years of experience in process validation within pharmaceutical or herbal manufacturing.
- Strong knowledge of GMP, EDA, WHO, and ISO 9001/22000 standards.
- Practical experience in equipment qualification, cleaning validation, and process validation.
- Familiarity with validation software, risk assessment, and data integrity principles.
Company Industry
- FMCG
- Foods
- Beverages
Department / Functional Area
- Doctor
- Nurse
- Paramedics
- Hospital Technicians
- Medical Research
Keywords
- Sr. Process Validation Specialist - Pharma
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