Main purpose of role:
* To write high quality technical analytical documentation and to undertake analysis as required.
* The job holder is required to work on their own initiative and largely independently on key responsibilities under the supervision of the Documentation Team Leader.
* The job holder is responsible for generating high quality analytical specifications ensuring consistent deliveries for technical documentation for work that falls within the Analytical Services group.
* Assist in the analysis of data to help identify areas of improvement primarily within the department but also across the business where appropriate.
* To interpret analytical data and generate comprehensive gap analysis, review reports, analytical protocols and reports in line with regulatory requirements and business proposals.
* To generate comprehensive analytical methods that are easily understood by analysts and technicians at all levels.
* To generate product and material specifications in line with customer and regulatory requirements.
* To update all above named documentation in line with PCI procedures.
* To ensure a consistent approach is taken to document writing and to ensure all protocols and reports are generated to a minimum of regulatory submission standard.
* To generate accurate cost proposals and change orders in line with service level agreements based on information supplied by the business development group.
* To review analytical and laboratory data within the department for accuracy, completeness and compliance with documented procedures.
* To communicate effectively with internal and external customers and participate with them in problem solving activities, as required.
* To assist in the analysis and presentation of departmental metrics data to aid in the selection of continuous improvement projects within the department and across the business where appropriate.
* To participate in identified continuous improvement projects within the department and across the business as required.
* To maintain a thorough understanding of international regulatory requirements pertinent to the team, and to ensure that all work within the team complies with these, with departmental procedures and the principles of Good Manufacturing Practice.
* To ensure ComplianceWire is kept up to date.
* Minimum first degree educated in Pharmacy, Chemistry or other life science
* Adequate experience in a pharma environment
* Excellent technical writing skills
* Proficient in the use of Microsoft Office
* In depth understanding of method validation at different phases of development and previous experience in writing technical documentation