Manufacturing Specialist (Pharma/Biotech)

Job Scope: To perform investigations, change plans or other functional support associated with cGMP manufacturing operations within the biologics production facility and work cross functionality. Responsibilities: Perform technical writing and investigation of non-conformances in collaboration with Operations Identify and put in place appropriate corrective and preventative actions in conjunction with Operations team Change Management Structure common Operations Training modules and Train new hires on such modules Trends Key Performance Indicators and implement measures to streamline work processes and procedures GMP Document Authoring and Revision Electronic Batch Record Co-Authoring, Revision and improvement Participates / leads operations improvements and new product introduction projects Work with Quality systems (e.g. CAPA and change plans) and Operations Related System (LIMS, SAP, PI, Maximo, MS Office) Assist in regulatory inspections, detailing investigations and change plans. Work on continuous improvement projects About You: BS (or equivalent experience), with at least 2 to 5 years of relevant experience Strong working knowledge of GMP systems such as Trackwise, SAP, LIMS, MES systems are preferred Experience with cGMP documentation and record maintenance Experience with Regulatory inspections is required Strong ability to lead and drive cross functional teams Excellent attitude towards work, with strong drive to drive tasks to closure Agility, able to work under stress and cater to different priorities Good presentation and strong technical writing skills Good interpersonal and communication skills Duration: 12 months