Quality Advisor

JOIN US IN OUR SITE QUALITY TEAM WITHIN DEVELOPMENT QUALITY!

Site Quality  provides Quality oversight in the development of Investigational Medicinal Products and have the responsibility for Licence to Operate for our development site and play an important part in the commercialization of new medicines.  Site Quality is a Global function, with teams located in Gothenburg (Sweden), Macclesfield, (UK), Durham (North Carolina, US) and Redwood City (US). With a portfolio encompassing both small and large molecules, combination products and cutting-edge technologies you will be a part of providing novel life-changing medicines to our patients around the globe. Ready to make a difference? Then Site Quality might be right for you!

We have exciting opportunity for a 12 months assignment as Quality Advisors, in the Site Quality Gothenburg team, who’ll be the prime source for quality & compliance advice and providing quality support to the science functions and throughout the drug development process chains.  This is a great opportunity for you who are strong in quality and like to work with Good Manufacturing Practice, validation and making sure quality is assured when delivering new products.  


THE ROLE:
AS A QUALITY ADVISOR, YOU ARE EXPECTED TO ASSURE THAT ACTIVITIES AND PROCESSES ACROSS THE DEVELOPMENT CHAIN ARE DELIVERED TO APPROPRIATE STANDARDS TO MEET REGULATORY EXPECTATIONS AND ASSURE PRODUCT INTEGRITY AND ACCEPTABILITY. THE QUALITY ADVISORS ARE RESPONSIBLE FOR QUALITY AND GMP COMPLIANCE AND DECISIONS HAVING AN IMPACT ON AZ DEVELOPMENT PROJECTS AND THEREFORE AZ’S BUSINESS AND EXTERNAL REPUTATION. THEY USE RISK MANAGEMENT TO EVALUATE COMPLIANCE ISSUES AND TO DEVELOP SOLUTIONS. THE DECISIONS ARE MADE AGAINST A BACKGROUND OF REGULATIONS THAT VARY DEPENDING ON THE STAGE OF DEVELOPMENT AND AGAINST A SET OF STANDARDS THAT REQUIRE INTERPRETATION.

THE ROLE HOLDER ARE EXPECTED TO DEVELOP AND MAINTAIN A KNOWLEDGE OF THE QUALITY REGULATIONS AND GUIDELINES APPLICABLE TO THEIR AREA AND BE DEVELOPING A DEEP SCIENTIFIC UNDERSTANDING OF GMP.

OPERATING AS PART OF A GLOBAL ORGANIZATION, WITH AN INTEGRATED APPROACH TO BUILD COMMON PROCESSES AND WAYS OF WORKING INCLUDES:
• PROVIDE DEVELOPMENT QUALITY INPUT THE REVIEW AND APPROVAL OF COMPUTERISED SYSTEM VALIDATION DOCUMENTATION AND DATA.
• RESPONSIBLE FOR QA APPROVAL OF DOCUMENTATION RELATED TO MANUFACTURING EQUIPMENT AND FACILITIES TO ENSURE GMP COMPLIANCE, INCLUDING MAINTENANCE, CALIBRATION, VALIDATION AND CHANGE CONTROL.
• RESPONSIBLE FOR DEVELOPING AND APPROVING GMP DOCUMENTATION.
• PROVIDE APPROPRIATE QUALITY ASSURANCE INPUT TO BUSINESS IMPROVEMENT PROJECTS.
• DRIVES, ROLE MODELS AND SUPPORTS A STRONG LEAN CULTURE THAT PROMOTES STANDARDISATION, SIMPLIFICATION AND CONTINUOUS IMPROVEMENT
• DEVELOPMENT, IMPLEMENTATION AND CONTINUOUS IMPROVEMENT OF GOOD MANUFACTURING PRACTICE (GMP) ACROSS THE FUNCTIONS
• PROVIDE ADVICE TO SUPPORT THE DEVELOPMENT, IMPLEMENTATION AND CONTINUOUS IMPROVEMENT OF GMP QUALITY SYSTEMS ACROSS THE FUNCTIONS AND SUPPORT IMPLEMENTATION OF AGREED GLOBAL STANDARDS.
• PROVIDE SUPPORT AND GUIDANCE TO FUNCTIONS TO SATISFY EXTERNAL REGULATORY AUTHORITY GMP INSPECTIONS.

MINIMUM REQUIREMENTS – EDUCATION AND EXPERIENCE

MSc in pharmacy or engineering (specializing in Pharmaceuticals) with at least 3 years’ experience of working within a pharmaceutical GMP environment
Experience of validation in GMP settings and especially computerised system validation
Broad understanding of Quality Systems and GMP
Comprehensive understanding of the pharmaceutical/drug development process
Good communicator with experience of interacting effectively across interfaces
Fluent in written and spoken English

PREFERRED REQUIREMENTS
Experience preferably within a Pharmaceutical Manufacturing organization
Experience of regulations
Good team working and networking skills
Capable of making effective decisions
Demonstrate a high degree of personal credibility

ABOUT ALTEN
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams! As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.

We believe in growing together!