Senior Validation Consultant

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.