Documentation Specialist

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Documentation Specialist

Exciting opportunity for a Documentation Specialist with our client, a leading multinational Pharmaceutical company based in Sowrds.

Responsibilities

Act as days operations member on process centered teams, working with technical operations and shift operations to identify, perform root cause analysis and develop corrective/ preventative actions for issues as they are occur.

·       Work as a key team member within the Downstream (DS) Integrated Process Team to ensure on-time delivery of the production schedule while maintaining alignment with site safety and quality standards.

·       Provide oversight on material management, ensuring quality and delivery metrics related to material management are always maintained.

·       Own Quality Investigation from identification through root cause analysis

·       Provide oversight on day-to-day production quality metrics ensuring on-time documentation closure, line clearance and material management as per area SOPs.

·       Drive continuous improvement projects related to schedule, equipment, and delivery capability within the DS IPT.

·       Act as a link between the shift operations team and days team, ensuring stardardisation and integration between all IPT teams.

·       Support audit readiness in the BDS and drive a permanent audit readiness culture within the team.

·       Direct Root Cause Analysis (RCA) sessions for both safety and quality related events, driving actions to closure with appropriate corrective/preventive measures.

·       Lead/support area change controls, CAPAs, QSAT actions as relevant per work stream as well as completing documentation updates as required.

·       Provide ongoing coaching and support to cross functional team members, to share process and operational best practices.

 

Requirements

·       A minimum of a Level 7 Degree in Science, Engineering, or other relevant disciplines/ relevant experience preferable

·       Experiences across multiple site functions (including but not limited to Quality, Engineering, or Supply Chain) desirable but not required.

·       Experience in change management in a GMP environment.

·       Experience in technical writing for GMP documentation and quality investigations.

·       Experience working with GMP Documentation Management Systems

·       Excellent verbal and written communication skills

·       Proficient in Microsoft Office Tools (word/excel/PowerPoint )

·       Ability to work independently and as part of a team in a cross functional collaborative environment.

·       High level of attention to detail