• Creating and implementing procedures necessary for a robust and compliant Commissioning, Qualification, and Validation Program (CQV); • Manage the development and maintenance of validation program documents including SOPs and Master Plans. • Lead and develop cleaning, equipment, computer and process validation efforts for the site. • Site commissioning and qualification procedures for building and process systems, cGMP equipment and systems (IOPQ); • Providing strong leadership, direction,
coaching and organizational planning for the team; • Managing CQV support of projects and manufacturing including financial tracking and reporting; • Working effectively with key business functions to ensure all site facilities, systems and processes remain in a validated state; • Acting as lead presenter during regulatory inspections for areas of responsibility as well as contribute to regulatory filings. To be considered for this role, you must possess: Bachelor’s degree in Engineering, technical or science related field, and post graduate qualifications will be highly regarded; 8+ years of progressive experience in qualification & validation of pharmaceutical/biotech operations obtain within a pharmaceutical manufacturing environment; 10+ years experience in successfully leading a team to drive change in a positive way; Demonstrated working knowledge of validation principles and cGMPs, FDA, TGA and EMA regulatory guidelines, including interaction with regulators; Well-developed analytical and problem-solving skills; Exceptional interpersonal and communication skills including collaborating, influencing, negotiating and presenting. In addition, the successful candidate must be: Highly analytical and an excellent problem solver; An outstanding communicator and able to collaborate, influence and negotiate at all levels across the organisation; Highly credible and experienced in presenting, including to regulators; Recognised as leader who is able to coach and develop a team; Experienced in successfully driving and managing change in the validation arena. If you are looking to develop your skills and shape the health of Australians, please apply with your resume and cover letter, which must address the selection criteria above, and include the reference number R-124805 Applications close Friday 20th November 2020
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