Data and Document Reviewer

The purpose of the job is to perform development and phase appropriate validation of analytical methods in support of API manufacturing projects for small molecules and/or peptides. These include, but are not limited to, determination of assay and related substances by HPLC/UHPLC/GC, determination of residual solvent content by GC, determination of water content by KF, counter ion content by IC. Additional activities include performing forced degradation studies and reference standard characterisation. • To demonstrate good understanding of the technical aspects of the job • To demonstrate good understanding of current internal procedures and regulatory aspects of the job • To maintain current knowledge of technical activities related to the job • To actively participate in customer visits and audits where necessary • To ensure that all scientific project work is completed to the required standard, within budget and to agreed project timelines • To take part in any other activities related to the job as requested by the line manager • To ensure work area is clean, tidy and housekeeping is of high standard • To ensure all reviewed data is attributable, legible, contemporaneous, original and accurate • To be able to adjust priorities appropriately to meet the project timelines Customer Focus Communication • To be responsive to internal and external customers requirements • To attend, actively and constructively participate in Team Meetings • To communicate project status internally with accuracy and clarity • To provide regular updates to your line manager • To maintain effective communication with own department • To contribute to technical discussions • To observe and adhere to the company's Equal Opportunities and Dignity at Work policies ensuring that a neutral and harmonious environment is maintained in which bullying and or harassment does not occur • To display high level of integrity when dealing with management, colleagues, clients, contractors and suppliers while representing Almac • To know, embrace and display all Almac's core values in every day-to-day activity in and outside work • To act as a positive role model for the organisation, fostering a climate of teamwork and continuous improvement • To actively promote an engagement and compliance culture within the team and the whole of Almac Sciences • To be accountable for all actions • To identify opportunities for process improvement and propose potential solutions with line manager or other senior colleagues • To review project data and identify trends in conjunction with line manager. • To comply with Almac policies and procedures • To report all accidents, incidents, near misses or any unsafe conditions in the workplace and propose preventative actions • To ensure the appropriate GMP procedures are followed consistently in all areas of work • To prepare and review data and documents accurately and efficiently, in line with the department's culture of Right First Time • To communicate deviations from GMP procedures in a timely manner • To be able to identify OOS, OOT, OOP and OOE results and to inform the appropiate member of staff according to procedure • To perform project work Right First Time to avoid repetition and to ensure timely completion of project deliverables

• To ensure that all training is recorded and up to date before undertaking any specific duties • To train less experienced scientists as required in the appropriate SOPs ESSENTIAL REQUIREMENTS • 5 GCSE (or equivalent) passes, grades A-C, in Mathematics and English Language or leaving certificate • Degree level qualification in an Analytical/Chemistry related discipline or equivalent experience • Higher Level Qualification in relevant discipline, including significant industry experience, may be considered in Lieu of Degree Qualification • Previous relevant laboratory experience in a GMP/GLP environment

• Working knowledge of multiple laboratory techniques • Experienced in the use of Microsoft Packages (Word, Excel etc) • Excellent communication skills (verbal and written) • Ability to apply attention to detail to tasks undertaken • Ability to organise and plan work both independently and in conjunction with team members