A. PRIMARY FUNCTION OF THE JOB :

1. To provide CQV expertise to project teams in the office or on sites

2. To provide CQV expertise on client's sites when such requests arise

B. BRIEF DESCRIPTION OF THE JOB AND RESPONSIBILITIES :

1. Should be a regulatory Compliance specialist

2. Assist in the production of Commissioning Qualification or Validation Master Plans, (under the supervision of the regulatory compliance specialist)

3. Help the team to Prepare and execute Risk Assessment protocols (System and Component Impact Assessment)

4. Guide the team to Prepare and execute Design Qualification protocols

5. Guide the team to Prepare and execute Installation Qualification protocols

6. Guide the team to Prepare and execute Operational Qualification protocols

7. Initiate and maintain a cGMP change control system during the validation program

8. Review design documentation to ensure CQV and general cGMP requirements are being provided

9. Participate in project Start-up activities including preparation and execution of Installation Verification and Operational verification documents (Commissioning)

10. Liaison with construction and relevant contractors for effective system handover both mechanical and E&I.

11. Knowledge of Delta-V or similar control system (preferred, but not essential)

12. Monitor that work and progress follow the project requirements and schedule. Maintain contact with other disciplines/groups to ensure:

a) Project Manager and/or Engineer are aware of problems of progress delays.

b) Proper interchange of information.

c) Proper interchange of documents

d) Interface is correctly defined.

13. Meet client expectations and maintain long-term relationship with client. Attend to client's feedback and any complaints

C. QUALIFICATIONS AND KEY COMPETENCIES (Education, Training, Skills, Experience) :

CQV Engineer :

- B. Pharma or degree in chemical, mechanical, or electrical engineering or Post graduate degree in Chemistry, Microbiology, Biochemistry or equivalent with appropriate industrial experience of CQV in pharmaceutical (12-15 years)

- Should be aware of regulatory requirements of USFDA, EU, MHRA and WHO etc.

D. ADDITIONAL COMPETENCIES (Education, Training, Skills, Experience) :

In order of priority :

- Experience of Commissioning Qualification and Validation in similar engineering company and project environment.

- Experience of Commissioning Qualification and Validation in pharmaceutical industry

- Experience with Regulatory and industry standards for GMP and GEP

- Experience using the ISPE baseline guides

- Self-starter

- Good team player

- Good oral and written communication skills

E. Employment Type : Full Time

F. Eligibility : Graduate or Post Graduate

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