Validation Manager / Associate Director

Summary

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

Job Responsibilities Role & Responsibilities

1. General:

a. Serve as SME for CQV for the Singapore facilities for Drug Product / Drug Substance

b. Ensure compliance with appropriate regulatory requirement and WuXi Biologics 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 a timely and compliant manner

g. Perform lesson learnt 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. Maintain site validation master plan and validation SOPs to maintain consistence of validation strategy with various sites of WuXi Biologics

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 pharmaceuticals 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 (21 CFR Part 11/210/211, EU GMP, GAMP 5, ICH Q9/Q10; ISPE Baseline Guides, and PDA TRs.)

2. Project management skills;

3. Good understanding of Quality System, EHS.

4. Strong collaboration, self-motivation, communication, problem-solving and influence skills

5. Demonstrated knowledge of pharmaceutical technology and processes