Quality Assurance Partner
Alten Sverige AB / Biomedicinjobb / Göteborg
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hela Sverige AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Our Development Quality (DevQ) team ensures the delivery of safe, effective and compliant medicines to patients participating in global clinical studies. We set standards and apply scientific and Quality expertise to our exciting drug pharmaceutical development portfolio and help maintain our reputation and license to operate. We also play an important part in the commercialisation of new medicines.
Development Quality is a Global group, with teams located in Macclesfield, (UK), Gothenburg (Sweden), Durham (North Carolina, US), Gaithersburg (US), Redwood City (US) and Bad Homburg (Germany).
The assignment is to create and implement a Global archiving process for Development Business (across PharmSci, PT&D and DevQ). The assignment also include driving a process improvement project for GMP training process. The role will also be accountable for the DevQ Business Process of Archiving and GMP training ensuring the use of AZ BPM framework within DevQ and across the development functions, PT&D & Pharm Sci. Ensure all applicable regulations and AZ standard is fulfilled by the process and has a holistic view to ensure alignment across related processes. Coach and advise users. Ensuring continuously learning across all processes. As Business Process Owner be accountable for the processes and leads the definition, design and ongoing improvement of the process to ensure; compliant to relevant requirement, efficient, effective and transparent ways of working.The role holder operates independently with minimal supervision. They use risk management to evaluate compliance issues and develop solutions. Their 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.
Generally, they are responsible for GMP compliance decisions having a major impact on AZ's business and external reputation related to GXP training and archiving.
ACCOUNTABILITIES AS BPO
The Business Process Owner is accountable for the process and leads the definition, design and ongoing improvement of the process to ensure; compliant to relevant requirement, efficient, effective and transparent ways of working.
Provide training materials, expert advice and coaching. Through metrics, identify issues and risks, escalate as required. Monitor internal and external signals and trends. Provide a business continuity plan for the process if required
Have a clear understanding of the relationship between operational requirements of a corporate business strategy and customer satisfaction
Assist the management team in the identification of BPO projects that encourage the completion of strategic business objectives.
Ensure risks of the process are identified and mitigated
GENERAL ACCOUNTABILITIES
DEVELOP AND MAINTAIN IN-DEPTH KNOWLEDGE OF THE QUALITY REGULATIONS AND GUIDELINES APPLICABLE TO THEIR AREA.
PROVEN ABILITY TO CONTINUALLY REFRESH CGMP INTERPRETATION AND APPLICATION THROUGH SELF-STUDY AND EXTERNAL INVOLVEMENT WITH INDUSTRY GROUPS.
MENTOR, SUPPORT AND INSPIRE JUNIOR COLLEAGUES FOR ENHANCED INDIVIDUAL AND TEAM PERFORMANCE.
WORK WITH THE TEAM LEADERS/QUALITY DIRECTORS TO DEVELOP AND IMPLEMENT GLOBAL OBJECTIVES.
BUILD AND MAINTAIN STRONG CUSTOMER RELATIONSHIPS WITH OTHER FUNCTIONS WHOSE ACTIVITIES OVERLAP, INFLUENCE OR AFFECT COMPLIANCE AND LEAD OR PARTICIPATE IN GXP AUDITS/INITIATIVES WITH OTHER AZ QUALITY GROUPS.
DEVELOP SOLUTIONS TO A DIVERSE RANGE OF PROBLEMS THAT REQUIRE COMPLEX JUDGEMENTS, USING HIGHLY DEVELOPED LEVELS OF CONCEPTUAL THOUGHT, STRATEGIC VISION AND ANALYSIS.
ENSURE APPROPRIATE QUALITY INPUT TO MAJOR BUSINESS IMPROVEMENT PROJECTS AND MAY LEAD PROJECTS ACROSS THE DEVELOPMENT FUNCTIONS.
SUPPORT ISSUE MANAGEMENT TEAMS ON ARCHIVING AND GMP TRAINING SPECIFIC ISSUES.
OPERATE CONFIDENTLY AS PART OF A GLOBAL ORGANISATION WITH AN INTEGRATED MINDSET TO CREATE AN ORGANISATION WITH COMMON PROCESSES AND WAYS OF WORKING.
DRIVES, ROLE MODELS, AND SUPPORTS A STRONG LEAN CULTURE THAT PROMOTES STANDARDISATION, SIMPLIFICATION AND CONTINUOUS IMPROVEMENT
MINIMUM REQUIREMENTS - EDUCATION AND EXPERIENCE
FUNCTIONAL & BUSINESS KNOWLEDGE
• APPROPRIATE SCIENTIFIC DEGREE WITH EXTENSIVE EXPERIENCE (5-10 YEARS) AND WITH A REPUTATION OF WORKING WITHIN A PHARMACEUTICAL GMP ENVIRONMENT, PREFERABLY WITHIN A PHARMACEUTICAL DEVELOPMENT ORGANISATION
• PROVEN AND STRONG EXPERIENCE IN BUSINESS PROCESS MANAGEMENT
• GOOD KNOWLEDGE OF ARCHIVING IN GMP BUSINESS
• STRONG ENGAGEMENT, COMMUNICATION AND STAKEHOLDER MANAGEMENT SKILLS, INCLUDING EXCELLENT PRESENTATION AND INFLUENCING SKILLS
• GXP TRAINING KNOWLEDGE
• GMP DOCUMENTATION
• GOOD KNOWLEDGE AND INSIGHT IN IT SYSTEMS
• PROBLEM-SOLVING APTITUDE, PREFERABLE LEANSIX SIGMA CERTIFICATION
SKILLS AND CAPABILITIES
• Experience in Business Process Management and how to apply Lean methods and Tool
• Experience and preferable skilled at facilitation
• Good team working and networking skills
• Excellent team working and networking skills and encourages team effectiveness
• Demonstrates independent judgement and uses risk management in complex situations
• Capable of making decisions, acting courageously and communicating with conviction and inspiration
• Demands excellence (sets high bar) and delivers
• A good communicator with experience of interacting effectively across interfaces
• Builds excellent relationships both internally and with external suppliers or service providers
• Demonstrates drive and energy in the role to make a difference.
• Demonstrates a high degree of personal credibility
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2021-06-23ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2021-07-02
Klicka på denna länk för att göra din ansökanFöretagAlten Sverige AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Alten Sverige AB (org.nr 556420-7453)
Jobbnummer 5828169
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