Technical Writer & Compliance Specialist - GSK Stevenage, England
Job description
Duties/Responsibilities
GSK Stevenage - base location, other sites includes GSK - Harlow and GSK - CUC Addenbrookes (Cambridge)
As Technical Writer
1. Creation and update of the following document types using up to date templates, to the required standard.
Standard Operating Procedures (SOP), Work Instructions (WI), Guidance Documents (GUI)
Associated Exceptions for above documents
Maintenance Training Aids
2. Communicate with the appropriate Stakeholder / Process Owner to progress document through life cycle.
3. Undertake document periodic reviews as required.
4. Comply with statutory requirements, regulations, and company procedures, including GxP and EHS standards.
5. Participate in Technical Writers Forum to ensure working inline with other groups and the client representatives.
6. Working with training team to determine the associated training requirements for new procedures.
As Quality Specialists
1. Support the compliance team in implementation of business requirements around GxP needs.
2. Provide support for issues related to third party contractors, equipment, systems or utilities having significant risk to the client operations.
3. Conduct appropriate assigned compliance internal audits on a regular and ad hoc basis.
4. Support Client & Regulatory assessments by planning and preparation, and facing the auditor as requested.
5. Control, monitor and complete where appropriate, assigned audit actions to ensure actions are closed out as required.
6. Assist in training sessions to ensure Engineering teams have an understanding of quality requirements and procedures.
7. Assist any member of the compliance team as required
8. Support the operations team in delivering the required compliance needs in GxP regulated areas and with the day-to-day site management when requested
9. Set, own and manage CAPA actions
10. Initiate engineering change controls, action, monitor and track to closure
11. Lead and participate in Engineering or Quality related deviations
12. Assist with writing and review of contract specific procedures as required
13. Represent the Quality Compliance function at EMCOR / Client meetings and presentations
14. Provide Quality support including staff training on required topics
15. Promote continuous system improvement and good practices
16. Proactively encourage the strict adherence to the Client procedures
17. Implement and monitor controls to prevent deviations and non-conformities
18. Complies with all Client and EMCOR policies and procedures and adheres to company standards
19. Sign GxP documents as required by procedure and based on appropriate training
20. Perform other duties as requested
21. Uses client systems such as EAM, IMMS, Beamex, CMX to extract and perform data management reviews in support of trend analysis, CAPA or deviation.
22. Ensure monthly reports/KPIs commitments are published and submitted to the Line Manager.
23. Maintain a quality culture between the Company, GSK R&D and Third-Party Contractors through good communication and documentation.
Person Specification
Degree HNC/HND / similar in Engineering or manufacturing within pharmaceutical/healthcare industry, or equivalent related work experience within a regulated manufacturing or processing environment
Background in technical authoring, preferably within Pharmaceutical / GxP environment.
Experience and knowledge of GxP guidelines and regulations would be advantageous
5+ years working in a regulated Engineering Quality, facilities maintenance, or a manufacturing operations organization
Computer literate with a sound knowledge of Microsoft Office products and experience of controlled document systems ideally Veeva Docs.
Good knowledge of documentation generation and amendment techniques and processes. Ability to understand the needs and demands of a diverse group of stakeholders
Ability to interpret requirements from source documentation.
Experience of working on projects with high volume of document change
Specialized training or certification in quality assurance audits preferred.
Ability to identify and act on Compliance Risks within responsible area.
Experience in review of audit related documentation.
Expertise with Microsoft Word, Excel and RCA Tools.
Experience of EAM asset management system, Trackwise, lMMS and Electronic Document management System – Veeva Vault (VQMS), is advantageous.
Excellent interpersonal and communication skills to effectively work with management and employees at all levels within an organization, including key stakeholders, customers and facing the regulatory auditor
Must have demonstrated experience in a safe, team-based, high performance, quality-driven environment.
