Senior Consultant (CQV SME)

* Supervised conceptual design, construction and commissioning of the new R & D facility
* Managed the Preventive Maintenance (PM) program development and execution of critical equipment and
support systems.
* Validation of Heating Ventilation and Air Conditioning (HVAC) systems, bio safety cabinets and balance
enclosures (positive pressure systems), glove boxes and isolators (negative pressure systems), facilities
air/pressure balancing
* Responsible for the annual certification of the manufacturing rooms to ISO standards (ISO6/ISO7)
* Supervised the R & D / GMP equipment calibration program development and execution

* GMP and R & D Facilities Design Review and Approval
* Batch Record, Compilation, Review & Issuance Disposition
* Supervised program in writing and execution of DQ, IQ, OQ, PQ protocols for equipment qualification
* Acted as QA liaison responsible for Corrective Actions Preventive Actions (CAPA) for R&D/Engineering
department
* Assistance to QA and Regulatory departments with Deviation/CAPA Management and resolution

* R & D and GMP equipment qualification (over 300 IQ, OQ and PQ protocols written and executed)
* QA documents from review from engineering stand point (batch records, SOP, WI, VP, VR, MVP)
* Assessing site facilities for compliance to GMP in preparation of novel manufacturing campaigns
* Assisted QA department with Deviation & CAPA Management in regards to engineering issues