Description
A pharmaceutical organisation based in South East England requires an individual to work as part of the client side team to oversee C&Q activities on their new build pharmaceutical project.Key Responsibilities:
* Generation of list of C&Q tests (Installation Verification (IV), Operational Verification (OV), Operational Qualification (OQ), Performance Testing (PT) and Performance Qualification (PQ).
* Execution of process commissioning & qualification tests in adherence with project schedule.
* Retain sole ownership and responsibility for commissioning and qualification documents from generation, through pre-approval, execution, post-execution review; and final sign-off.
* Acting as the interface between the Client and the designated Engineering company who are handling the activities up to OQ.
* Support process validation activities and CIP/Cleaning verification during the handover/Operational period.
Ideal Skills and Experience:
* Degree or HNC/D qualified in an Engineering based subject or related experience in an Equipment/Commissioning/Validation role.
* Experience within Primary API manufacturing environment responsible for commissioning, qualification and process qualification of equipment to include Pan-dryer, Wipe film evaporator, Super critical extraction, Mobile vessels and filtration vessels.
* 7-10 years’ experience in process commissioning & qualification in the chemical/pharmaceutical industry.
* Familiarity with unit operations involved in the manufacture of active pharmaceutical ingredients (API’s).
* Compilation and development of associated Commissioning, Qualification and Validation documentation in line with GMP standards.
Please apply now for more information.