Operational Quality Manager

• Ensure Quality Incidents associated with products manufactured and packed with In the Value
• Stream are managed in line with the QMS and local procedures.
• Manage LIC, PIRC, Recall functions In coordination with Site Quality Head.
• Ensure that there is effective management of investigations (including CAPA) and assessment of
data from products failing to meet requisite standards and make batch disposition decisions on rejection or rework in consultation with the Site • Quality Director, Value Stream Manager and Site Director as appropriate.
• Influence Quality Improvement programs (QIP )and work with the appropriate Value Stream
• Manager and technical colleagues with the aim of reducing rejects and customer complaints and
• In doing so achieve a right first time/by first intent culture.
• Handle investigations of deviations, Data integrity deviations, complaints, OOS & OOT results, in coordination with production supervisors, •Labs, Warehouse and ensures implementation of appropriate CAPA & ensure investigation closure within specified time with intended Quality requirements
• Manage the Quality and where appropriate the Technical interfaces between the Site and Auditors during Audits.
• Sign-off the Stream Periodic Product Reviews.