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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: sujatha.kolluru@gallop.net

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

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