LM Manufacturing Limited, Weedon Bec, NorthamptonNN74PP (United Kingdom)
*Building a team of 40 personnel on site with various technical capabilities in Quality Assurance,
Production, Warehouse, Quality Control, Engineering and Validation.
*Developing Quality management system on site in compliance with current EU guidelines for GMP, GDP
in-house Standard operating procedures, core documents i.e. Site Master file, Quality manual, Site
validation masterplan etc.
* Auditing vendors of API, Primary packaging materials, Warehousing facility to assess suitability
with relevant Guidelines and approving them for use.
* Assisting Qualified Person (QP) in Quality Management System related issues at Site. meeting the
statutory/Regulatory requirement.
*Designing /Commissioning and monitoring the internal quality audits, escalating it to Senior
management as part of periodic Quality Review and identify the risks associated with the facility
and products.
*Identifying to impart/arrange training on various GMP topics like Cleaning Validation, Impurity
profile, Method validation, Audit & compliance, Quality Risk assessment etc. and arrange external
training whenever required.
*Leading and managing the strategic and operational performance of the Quality department, ensuring
the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives,
whilst adhering to regulatory compliance and achieving commercial success. Preparing, reviewing and
approving Technical and Quality Agreements with all service providers.
*Acting as nominated person for manufacturing and storage of controlled drugs in accordance with
Home Office regulations.
*Ensuring good relations and communications with all members of the team and in a timely manner to
internal and external customers.