• Responsibility for the timely, accurate, and efficient management of documents including access and revision control.
• Manage “Live” Documentation updates from the Operations floor
• Turnaround and issue documentation as per Operations Schedule
• Manage and implement on the floor documentation control system
• Drive the Documentation Life Cycle System to ensure documents are approved in as per Scheduling requirements.
• Work with various Subject Matter Experts to ensure technical documentation updates are approved.
• Creation and revision of Standard Operating Procedures (SOPs) Work Instructions (WI’s) as required
• Work closely with QA, Supply chain, and Operations core functions
• Ensure compliance with all regulatory GMP, Safety, and Environmental requirements.
• Support the deviation process including co-ordination of shift-based deviations and tracking to closure.
• Assist in the write up of deviation incidents and link in with SMEs to address comments
• Manage day to day compliance metrics across the Upstream organization
• Support GMP Audit readiness and Compliance walkdowns.
Minimum Qualifications and Experience:
At minimum level 6 in a relevant Qualification
Key Competencies & Experience:
Self-motivated with excellent organizational skills
Experience Working in a Pharmaceutical GMP regulated industry desirable
Excellent verbal and written communication skills
Ability to work independently and as part of a team in a cross-functional collaborative environment
High level of attention to detail
Experience working with GMP Documentation Management Systems
Proficient in Microsoft Office Tools (word/excel/PowerPoint)