Website:
vrrlifesciences.com
Job details:
Job Summary:
We are looking for an experienced Cleaning Validation professional with 6–8 years of experience in the pharmaceutical industry. The ideal candidate should have strong expertise in cleaning validation and process validation, with a thorough understanding of current GMP requirements, regulatory guidelines, and validation lifecycle activities.
Key Responsibilities:
- Plan, execute, review, and maintain Cleaning Validation activities for manufacturing equipment and facilities.
- Prepare and review Validation Master Plans (VMP), validation protocols, reports, risk assessments, and SOPs.
- Design and establish cleaning validation strategies, including worst-case product selection, sampling methods, acceptance criteria, and recovery studies.
- Perform cleaning validation studies for new equipment, products, and change control activities.
- Coordinate and execute Process Validation activities, including protocol preparation, execution, data analysis, and report generation.
- Ensure compliance with cGMP, data integrity, and regulatory requirements such as US FDA, EU GMP, MHRA, and WHO guidelines.
- Support qualification activities, including IQ, OQ, and PQ, where required.
- Investigate validation deviations, out-of-specification results, and implement effective CAPA.
- Participate in regulatory audits and customer inspections and provide validation-related documentation and responses.
- Work closely with Manufacturing, Quality Assurance, Quality Control, Engineering, and Regulatory teams to ensure timely completion of validation activities.
- Review periodic validation status and recommend revalidation when required.
- Maintain validation documentation in compliance with company procedures and regulatory expectations.
Required Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, Chemical Engineering, or a related Life Sciences discipline.
- 6–8 years of hands-on experience in Cleaning Validation and Process Validation within a pharmaceutical manufacturing environment.
- Strong knowledge of cleaning validation concepts, MACO calculations, PDE/HBEL-based cleaning limits, swab and rinse sampling techniques, recovery studies, and validation documentation.
- Good understanding of Process Validation, equipment qualification, risk assessment tools, and validation lifecycle.
- Thorough knowledge of cGMP, Data Integrity (ALCOA+), and regulatory requirements including US FDA, EU GMP, PIC/S, WHO, and ICH guidelines.
- Experience in handling regulatory audits and inspections is preferred.
Click on Apply to know more.