Job Purpose
Provide scientific / technical support for lab equipment validation / revalidation and requalification activities including computerized systems performed in compliance to cGMPs, SOPs and applicable guidelines and normatives, with continuous improvement in quality and efficiency.
Major Accountabilities
Validation – draft, execution and review of protocol / report
Development validation protocols from Validation Plans.
Perform lab equipment including computerized systems validations, revalidations, requalifications, and on-site projects. Liaising with all the relevant parties cross functionally to ensure accurate and timely execution.
Author summary reports and ensure that are technically correct and comply with internal and external requirements.
Perform Lab Equipment Validation Maintenance Review and re-qualification activities to ensure GMP equipment is continuously maintained in a validated state.
Support with decommissioning of the lab equipment.
Perform investigations to the discrepancies during validation and qualification / re-qualifications, if any.
Participate in the coordination of efforts of multi-disciplined project team on the writing, performance, documentation and approvals of validation lifecycle documentations.
Participate in review of Vendor Validation Protocols / Reports including discrepancies investigation / closure
Ensure approval of validation documentation on a timely basis.
Ensure protocols are executed as intended according to the study plan/approach.
Assure high scientific quality of all studies and that they are carried out in a safe manner.
Requirements
A minimum of 3 years’ experience in Pharmaceutical manufacturing and cGMP environment. In depth knowledge of cGMPs and validation.
Familiarity with Regulatory requirements and local Codes & Standards (e.g.FDA, EMEA,GAMP and ICHQ7)
Significant experience within the biotech industry, preferably directly with Lab Equipment Qualification (LEQ) experience.
Experience in a GMP facility, with strong knowledge of GMP regulations.
Hands on working experience on Validation and QA experience is preferred.
Working experience with validation procedures.
Must be able to effectively multi-task and work independently, project management skills highly desired.
Strong communication skills and self-motivated.
Team player, with strong focus on safety, quality and timelines
x
