QA Validation Manager

Job Title: QA Validation Manager

Location: Singapore

Job Type: Full-time

Job Description:

Position Overview: Our client is a global pharmaceutical company, seeking a highly motivated and experienced QA Validation Manager to join their dynamic team. The successful candidate will be responsible for overseeing and managing the validation and qualification activities to ensure compliance with regulatory requirements and company standards.

Key Responsibilities:

• Develop and implement validation and qualification protocols for equipment, processes, and systems.
• Oversee the execution of validation activities, including process validation, cleaning validation, and computer system validation.
• Ensure all validation activities comply with cGMP, FDA, EMA, and other regulatory requirements.
• Manage the preparation and review of validation documentation, including Validation Master Plans, protocols, and reports.
• Lead and coordinate cross-functional teams to ensure timely completion of validation projects.
• Conduct risk assessments and manage change controls related to validation activities.
• Provide training and guidance to team members on validation best practices and regulatory requirements.
• Participate in internal and external audits, and address any validation-related findings.
• Continuously improve validation processes and procedures to enhance efficiency and compliance.
• Serve as the subject matter expert for validation during regulatory inspections and customer audits.

Qualifications:

• Bachelor's degree in a scientific discipline or related field.
• Minimum of 5-7 years of experience in QA validation within the pharmaceutical industry
• In-depth knowledge of cGMP, FDA, EMA, and other relevant regulatory guidelines.
• Strong understanding of validation principles and practices, including process, cleaning, and computer system validation.
• Excellent project management and leadership skills.
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills.
• Proficiency in Microsoft Office applications.

Preferred Qualifications:

• Experience with data governance and metrology.
• Familiarity with GAMP, 21 CFR Part 11, and EU GMP Annex 11 requirements.