Validation Lead

24 hours ago

Singapore Wuxi Biologcis Full time

**Job Summary：**

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

**Job content：**

1. Global Validation System Management (GENG Related, during project phase)

a) Establish and maintain the global validation system, including facilities and utilities qualification, manufacturing equipment qualification, cleaning validation, and shipping validation, etc. to maintain the consistence of validation strategy of various sites of WuXi Biologics

b) Track the update of regulations and guidance periodically, understand the current trends of pharmaceutical industry, Integrate the requirements from regulations, industry good practice (Such as ISPE guidance, PDA technical report), align with QA and other function teams to adjust the company-level validation strategy

c) Develop validation management tools for optimizing C&Q projects is better

2. C&Q (Singapore Project & Site)

d) Serve as C&Q leader and as SME for C&Q of equipment, facility and utility, as well as PPQ, Cleaning Validation, Shipping Validation, providing strategic guidance and knowledge to Singapore facilities

e) Develop and update site validation SOPs

f) Draft C&Q VMP and project schedule, review C&Q deliverables and manage C&Q activities, coordinate internal and external resource to solve the C&Q issues

g) Track the C&Q schedule and ensure adherence to schedule

h) Lead resolution of validation variance / issues in a timely and compliant manner

i) Ensure compliance with appropriate regulatory requirement and construction code

j) Ensure qualification status of site through re-qualification program and change control system

k) Support engineering related audit/visit by clients and regulatory authorities

l) Perform lesson learnt to share experiences and implement best practices;
m) Provide training and guidance on SOP and skills to team including vendors.

n) Lead the team to support authority inspections and client audits.

o) Responsible for validation team building, training and improving the team’s capability.

**Requirements：**

1.Bachelor degree or above, in Chemical Engineer, Biological Engineering or Pharmacy.

2. Demonstrated experience in validation or QA related work experience in cGMP environment (8 years as a guide)

3. Demonstrated experience in team management and development experience (3 years as a guide)

4. Demonstrated experience in audits by EMA, FDA and other international authorities is preferred

5. Familiar with pharmaceutical production process, cleaning process and sterilization.

6. At least skilled in two aspects of C&Q, cleaning validation, shipping validation and CSV

7. 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.)

8. Project management skills;
9. People management skills

10.Good understanding of Quality System, EHS.

11. Strong collaboration, self-motivation, communication, problem-solving and influence skills;
12.Fluent in written and verbal English.

**Salary**: $10,000.00 - $17,000.00 per month

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