We have an Opportunity for Senior product transfer manager role in a global pharamceutical company .
What Youll Do: Project Management of and participation in technical transfer activities with associated document authoring and review including Project budget planning and control.
Provision of technical support and expertise to all relevant activities within the business unit
Project management of assigned projects including to monitors execution of product supply integration plan from Global Operation perspective; highlight risk and s:
issues (with proposed mitigation plan) to line manager that could impact on continuity of product supply during transition period from seller .
Authoring review and approval of technical documentation (BMRs technical reports and summaries etc) to support manufacturing & regulatory activities.
Review and approval of sections of Regulatory Dossiers (Module 2 and Module 3) in CTD format for use in all submission related activities.
CMO site attendance as required to resolve manufacturing/technical issues affecting continuity of supply of products .
CMO site attendance to support key strategic initiatives such as Technical Transfer of Products and Processes introduction of new APIs or any other projects requiring Technical Support or Project Management.
Other tasks as delegated by Line Manager which contribute to overall running of the business unit. About You We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role
you will also have the following:
Qualifications
Graduate with Chemistry Pharmacy; or other technically relevant graduate level qualification. A post graduate Degree/doctorate is desired in similar fields. Knowledge
Skills & Experience:
Must have significant experience in a technical role (Production/QA/Formulation development regulatory CMC) within the pharmaceutical industry in regulated markets.
Excellent technical knowledge of all solid semisolid & liquid pharmaceutical dosage forms including sterile products.
Managed several technical and/or scientific projects of varying complexity.
In depth working knowledge of project management methodology (e.g. Prince 2) and practical experience with project management tools e.g. MS Project).
Ability to work under pressure and to tight time deadlines.
Good Presentation Analytical (data rational) and Planning skills.
Strong attention to detail and proactive approach.
Proactive nature with focus on proactive prevention of possible issues.
Excellent interpersonal communication and organizational skills Influencing / Assertiveness.
Persists with challenging situations does not give up in spite of barriers and obstacles.
Ability to demonstrate strong Project Management skills on time delivery of actions from cross functional teams timely resolution of issues and excellent budgetary control.
A positive and can do approach biased towards finding solutions and embracing change.
Inspired by our values of entrepreneurship speed and integrity.
Learning agility and scalability with a desire to continuously improve and develop as ADVANZ grows.
Work collaboratively across all business functions with an open honest and respectful cooperation.
Ability to have fun and thrive in a growing unique and inclusive work environment
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