Description:
Function: Senior Validation Expert
- A highly skilled and experienced Senior Validation Consultant with expertise in validation/re-qualifications of Equipment/System including Project work/Changes/CAPAs.
- In addition, knowledge of steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies & validation related to within the pharmaceutical industry.
- You will play a critical role in ensuring compliance with regulatory requirements and industry standards while optimizing operational efficiency and product quality.
Key Responsibilities:
- Lead and participate in equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Support execution of validation protocols/plans for Validations/Re-qualifications of steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, smoke studies/air flow visualization studies
- In case of deviations, Document, notify & co-ordinate for corrective action, and close out.
- Provide technical expertise and guidance on validation-related issues to project teams and stakeholders.
- Collaborate with cross-functional teams to ensure validation activities align with production schedules, project timelines and quality expectations.
- Conduct risk assessments and impact analyses related to validation activities and propose appropriate mitigation strategies.
- Draft, review and assess validation data, deviations, and change controls to ensure compliance with regulatory requirements and client’s internal quality standards.
- Ensure adherence to Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) during validation activities.
- Support during internal/external inspections/Audits in addition to representing relevant topics as an SME & having solid knowledge to communicate with authorities.
- Mentor and provide training to junior validation team members, sharing knowledge and best practices.
Your Profile:
- Bachelor's or higher degree in a relevant scientific or engineering discipline.
- Minimum 4~5 years of experience in validation/CQV within the pharmaceutical industry, Knowledge of experience in GMP including V-Model & SDLC methodologies.
- Strong analytical, problem-solving, organizational and project management skills.
- Team player with attention to detail and strong can-do mentality
- Excellent written and verbal communication skills, including the ability to effectively collaborate with multidisciplinary teams.