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*Job Title: **Senior Specialist (QA IT) IV* *Location: **Wayne, PA* *Duration: **3 months- end* · Support the global development and implementation of corporate policies, SOP’s and working practice documents to facilitate continuous improvement of performance and compliance 10% · Review and approve qualification and validation documentation in a timely manner ensuring compliance with GMP. Assure that all calculations and data are correct and any observations/non-conformances are properly investigated and explained. 30% · Communicate with other departments within Shire on quality and compliance issues. Effectively communicate possible cGMP deficiencies and validation concerns appropriate departments.10% · Support / complete as required Periodic Reviews, self-inspections and or Supplier audits 10% · Evaluate change control documentation for compliance/validation/GXP impact and determine validation requirements for that change. 10% · Stay current with changes to the relevant industry legislation and guidance documents so that Shire’s IT compliance policies / Quality Manual sections are current. 5% · Participate in IT project meetings and give input on QA issues related to CSV. 5% · As required, assist in regulatory inspections regarding IT validation activity. 5% · Participate if necessary and provide input in internal cGMP audits. 5% · Initiate new policies SOPs and WPDs or revise existing policies SOPs and WPDs as appropriate for IT QA as needed. 5% · Provide backup for other IT QA personnel 5% *Mandatory Skills* *Key Skills and Competencies:* · Excellent communication and technical writing skills · Ability to mange priorities time effectively to meet set goals and timelines. · Ability to work collaboratively with other functions on a global level, influencing buy in from third parties to produce planned outcomes. · Representing GQA in a professional and diplomatic manner at all times, being sensitive and considerate to the views of others. · Recognising when the skills and knowledge of others is required and involving the appropriate personnel accordingly. · Ability to think objectively and concisely to determine the appropriate course of action to facilitate the timely progression of IT compliance and Validation activities. *Complexity and Problem Solving*: · Logical, analytical thinker, able to understand the significance of a particular issue. · Ability to use personnel insight to conceptually solve problems and suggest appropriate solutions. · Ability to recognize where input is required at a more hierarchically senior level, escalating appropriate issues to the Associate Director IT QA, offering proactive solutions. *Education Requirements* · University degree or equivalent qualification, preferably in a life sciences subject. · Experience of working with Quality Systems and Information systems · Appreciation of Pharmaceutical dosage forms and relevant Global GMP legislation and guidance · Knowledge of GAMP and computer software validation experience is preferable. · Articulate, computer literate, good analytical skills, problem solving ability, decisive, good interpersonal and influencing skills *Sujatha| Gallop Solutions.* *Email ID: **[email protected]* <[email protected]> *Ph: 972-756-0622 Ext: 360* *630 Freedom Business Center, 3rd Floor * *King of Prussia, PA 19406 USA* http://www.linkedin.com/company/gallop-solutions This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please notify the sender. Views or opinions presented in this email are solely those of the author and do not necessarily represent those of the company. The recipient should check this email and any attachments for the presence of viruses. The company accepts no liability for any damage caused by any virus transmitted by this email. -- You received this message because you are subscribed to the Google Groups "Citrix and Sap problems" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/citrix-and-sap-problems. For more options, visit https://groups.google.com/d/optout.
