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