Description
The QA Documentation Specialist will be supporting the Systems Improvement project will work within the Global Quality Assurance function, providing oversight of CGMP and quality related activities in support of key project activities at ADL. In this capacity, the role may involve supporting other key functional areas including engineering, validation, training, Quality, Manufacturing, Process Development and Supply Chain groups.Key activities include but are not limited to;
-Technical Writing/SOP Compilation for Quality and other key functional areas.
-cGMP documentation review and approval.
-Implementation of procedures in accordance with cGMP requirements
-Executing activities in support of aligning site and corporate compliance standards - gap assessment execution, closure of gaps and corrective actions required in support of same.
-Controlling and archiving of cGMP documentation
Other activities may also extend to supporting sustained operational activities including;
-Batch record review and approval.
-Quality Systems support e.g. Auditing, Complaints, Supplier Qualification, Change
-Control, Investigations, Quality Risk Management.
-Maintenance and preparation of key quality metrics and KPIs.
-Tracks CAPAs detailed in Deviation reports -
-Training-
Candidate Requirements:
-Excellent QA experience within a global QA team setting.
-Preferentially - Experience gained within a pharma/bio-tech industry -
-Strong communication skills; the job holder will be required to work closely with both internal and external stakeholders and should be capable of working both independently and within a team setting.