QA & Compliance Manager

Job description:

Department: Quality and Compliance

Position: Quality & Compliance Manager

1. Monitoring of cGMP and GLP compliance and compliance to applicable regulatory requirement and filing commitments.

2. To ensure that approved SOP exist for operations pertaining to compliance to cGMP requirement and applicable GMP regulations.

3. To consistently drive company's ethics and data integrity policy.

4. To develop and / or monitor the system for approval or rejection of documents.

5. To implement effective monitoring and control procedure to achieve Quality system objective.

6. To review and Approve/Reject the Quality Management System documents such as change control, deviation, CAPA, laboratory and production failures investigation, OOS, OOT, LIR, market complaints, product recall etc.

7. To review and approve risk assessments.

8. To provide necessary support and inputs to R & D during products/process development, technology transfer and new product launches.

9. To represent unit during internal/external inspections and ensure compliance to cited deficiencies/nonconformities and escalate to management and handle Field Alert Reports, Product Recalls.

10. To review and effective monitoring of any market complaint and to ensure the proper execution of the global product complaint process along with corrective action.

11. To evaluate and budget for necessary resource personnel, equipment, facility etc. and monitor the performance of quality functions.

12. To ensure and monitor adequate warehousing arrangement, manufacturing and the testing environment, Storage space for documents and reference / intermediate samples.

13. To prepare, review and approve the apex documents such as Site master file, validation master plan and Departmental manual.

14. Implementation of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP).

15. Up keeping the Quality control laboratory in compliance.

16. To ensure that Laboratory has required SOPs, Standards, and Specifications & Methods of analyses to perform the testing activities assigned to Microbiology laboratory.

17. Ensure complete compliance to Organizations Ethics & Data Integrity policy and escalate any potential deviations to Management.

18. To ensure smooth transfer of technology of product manufacturing and analytical methods from other Dynamic Biologics groups of company to production and Quality Control laboratory.

19. To monitor the performance of Quality function and give necessary feedback to related personnel.

Education : Master's degree in Pharmacy, Pharmaceutical Science or relevant field

20. To evaluate the resources required for smooth functioning of the laboratory and to strive for the continuous improvement in quality, compliance & efficiency.

Required to stand, walk, sit, talk and hear; required to use hands to operate vehicles and office equipment; must be able to occasionally lift and/or move up to 50 lbs; specific vision requirements for this job include: close, distance and peripheral vision, and the ability to adjust focus, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position without compromising patient care.   

· KriGen Pharmaceuticals LLC dba Dynamic Biologics is an equal opportunity employer.  All employment decisions are made without regard to age, color, race, ancestry, national origin, disability, genetic information, military status, religion, creed, sex, pregnancy, childbirth, marital status, citizenship, sexual orientation, gender identity, gender expression, legally protected medical condition, or any other basis prohibited by applicable law.  Background checks and drug screens are part of our hiring process.  Affirmative Action/Equal Opportunity Employer, Minority/Female/Disabled/Veteran.

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• What is your salary expectation? (Required)

Education:

• Master's (Preferred)

Experience:

• Pharmaceuticals Manufacturing : 10 years (Preferred)

Work Location: In person