Validation Manager / Associate Director

Wuxi Biologics Biopharmaceuticals Singapore Private Limited; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading biopharmaceutical company in Singapore is seeking a Validation Manager to oversee validation and qualification activities from requirements analysis to manufacturing. The ideal candidate will have over eight years of experience in a cGMP environment and a background in engineering. Responsibilities include developing validation SOPs, managing CQV activities, and ensuring compliance with regulatory requirements. Strong project management and collaboration skills are essential for success in this role. Competitive compensation and benefits are offered.

Qualifications

• 8+ years of experience in validation or QA in a cGMP environment.
• Experience in start-up facilities and audits by EMA, FDA preferred.
• Familiar with pharmaceutical production process and equipment validation.

Responsibilities

• Manage validation & qualification activities from development to manufacturing.
• Develop validation SOPs and C&Q deliverables for project start-up.
• Serve as CQV SME and ensure compliance with regulatory requirements.

Skills

In-depth knowledge and experience of regulatory requirements

Project management skills

Good understanding of Quality System, EHS

Strong collaboration and communication skills

Knowledge of pharmaceutical technology and processes

Education

Bachelor degree or above in Engineering Discipline

Job description

Summary

Manage validation & qualification activities and system lifecycle from requirements analysis or product development to manufacturing, for equipment/facilities/utilities.

Job Responsibilities Role & Responsibilities

General:

• a. Serve as SME for CQV for the Singapore facilities for Drug Product/Drug Substance
• b. Ensure compliance with appropriate regulatory requirement and WuXiBiologics requirements

2.C&Q (Singapore Facilities Start-up)

• a. Develop validation SOPs and C&Q deliverables for project start-up and operation readiness
• b. Plan, manage and coordinate C&Q activities with internal and external resources/stakeholders
• c. Review C&Q deliverables from equipment suppliers / C&Q service providers, develop C&Q documents if required
• d. Attend equipment FAT/training as required
• e. Track the C&Q deliverables and ensure adherence to schedule from project to operation readiness
• f. Lead resolution of validation variance / issues in timely and compliant manner
• g. Perform lesson learned to share experiences and implement best practices;
• h. Provide training and guidance on SOP and skills to team including vendors

3.CQV (Singapore Facilities Operation)

• a. Ensure and track qualification status of site through re-qualification program and change control system
• b. Serve as CQV SME to support the site in audit / visit by clients and regulatory authorities c. Manage and coordinate CQV activities, and develop validation plans if necessary for NPI, Improvement Projects and Shutdown
• d. Maintains site validation masterplan and validation SOPs to maintain consistency of validation strategy with various sites of WuXiBiologics

Qualification

Education

• 1. Bachelor degree or above, preferably in Engineering Discipline

Experience

• 1. Demonstrated experience in validation or QA related work experience in cGMP environment (8 years as a guide)
• 2. Demonstrated experience in start-up facilities
• 3. Demonstrated experience working in pharmaceutical facilities in SG, EU or US.
• 4. Demonstrated experience in audits by EMA, FDA and other international authorities is preferred
• 5. Demonstrated experience in managing project and team management is preferred.
• 6. Familiar with pharmaceutical production process and equipment validation (Filling Lines, Lyophilization, Aseptic Process Simulation and Computerized System Validation in Drug Product, or Upstream and Downstream Equipment, Cleaning Validation and Sterilization Validation in Drug Substance)

Skills

• 1. In-depth knowledge and experience of regulatory requirements and industry standards (21CFR Part 11/210/211, EUGMP, GAMP5, ICHQ9/Q10; ISPE Baseline Guides, and PDATRs.)
• 2. Project management skills;
• 3. Good understanding of Quality System, EHS.
• 4. Strong collaboration, self-motivation, communication, problem-solving and influences skills
• 5. Demonstrated knowledge of pharmaceutical technology and processes