Quality Assurance Specialist - AstraZeneca

Job Description

• Participates in the development of Global AZ Affiliate Quality Strategy and executes country strategy for Affiliate Quality and Marketing Company GMP/GDP aligned with AZ’s 2030 bold ambition strategy for market expansion, product launches and accessibility.
• Is the responsible party for overseeing the design, implementation and delivery of a common Quality system and strategy for GMP and GDP activities across in Commercial marketing company for all of the AZ product portfolio in country
• Accountable for assurance of compliance with worldwide standards for all SA MC GMP & GDP activities and connects the affiliate offices the broader Operations Quality and R&D organisation operating under One AZ QMS.  

Typical accountabilities will include:

• For the African Cluster develop, support and drive excellence in Affiliate GMP & GDP Quality activities to maintain the MC License to Operate in the African cluster.? 
• Point of GMP & GDP contact for the country and maintains an effective governance structure to ensure oversight of quality activities. 
• Provides input for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and activities across market and commercial SET area as the Quality partner to Commercial SET leader, Regional Commercial Head and Global Safety
• Participates in defining the strategy for the commercial global markets ownership and execution of Affiliate GMP and GDP Quality System and framework in African cluster
• Participate in defining, developing, deploying and monitoring the GMP/GDP policies and standards and execution in country market
• Assist with  SA MC Affiliate Quality Management Review process, preparation and execution and escalations to Operations, Commercial and R&D Sr. Leadership and SET members
• Represents Quality on cross-functional and cross SET teams and steering committees related to Affiliate market.
• Participates in driving global standardisation, simplification and improvement of SA Affiliate Quality business processes.  Participates in developing and sustaining a high-quality organisation that delivers against global processes, and aims to continuously improve in competence, compliance standards and innovative delivery of results.
• Participates in providing training, supporting and coaching structure for regional Quality Affiliate network roles.
• Participates in strategy and regional objectives setting for the  Affiliate Quality organisation

• Is the secondary point of expertise for GMP & GDP activities impacting the MC affiliate organisation
• Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as well as common GxP process across the Affiliate GxPs.
• Accountable for Country specific regulatory requirements related to manufacture and distribution of AZ product in country, including but not limited to release of product batches, resolution of Issue Management, recalls, influence and decisions on MC regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ license to operate.
• Share in responsibility for Affiliate GMP & GDP input into divestments/acquisitions/licensing agreements in country
• Demonstrated ability to work independently and in project settings to deliver objectives.
• Keeps own knowledge of best practices, industry standards and new developments in quality management up to date.
• Participates in trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments in AstraZeneca’s Quality related needs
• Responsible for managing Quality Standards and expectations across a broad range of services in order to provide a high quality, timely and cost-effective service
• Employs prepared information to discuss, plan and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations
• Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Laboratory Practice and regulatory requirements of own work and others work
• Responsible for ensuring that policies and standards meet regulatory requirements
• Ensures compliance with Good Manufacturing Practice, Safety Health and Environment and all other relevant regulations
• Carries out compliance reviews and reporting for external suppliers including issue resolution with senior management and AZ site leaders, this may include, but is not limited to, the review and approval of investigation reports and participation in issue management teams
• Assisting with responsibility for MC preparing for Regulatory Agency and AstraZeneca inspections/audits and responses
• Supports MC to deliver the license to operate, including but not limited to support for GMP&GDP audits and inspections, implementation effective self-assessment programs in the country of responsibility.
• Responsible for ensuring QMS compliance and continuous improvement in the Region and all issues are managed concerned and closed on time, risks are identified and escalated to Global Quality.
• Promotes a Quality Culture in the Affiliate sets strategy in the region and in MC for execution of GMP/GDP excellence.
• Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans.
• Adheres to Good Manufacturing Practice and Safety Health and Environment and ensures regulatory compliance
• Contributes to development procedures in area of specialism and provides some technical input into the development of global standards for function and globally
• Proactively looks for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring and appropriate level of compliance
• The jobholders are directly involved with/lead working groups, teams, and projects to proactively provide a global perspective and to drive consistency and standardization in all matters related to quality and GMP compliance

Specific Requirements:

• Quality Management Review (QMR) Process Management
• Management of Product Quality Complaint & Champion /Reconciliation with Patient Safety
• Quality Issue/Deviation Management
• CAPA & CAPA Effectiveness Management
• Quality Risk Management & Risk Register
• Change Control Management
• Temperature Excursions (Logistic Incidents)
• Post Importation testing (Samples and Reference Standard management) and exemption application(PITE)
• Technology transfer to local labs involving manufacturing sites
• Product launches
• Product Quality Review
• Quality Assurance Agreement
• Mock Recall/Recalls/IMT
• Physician Sample management
• Customer verification Management
• Vendor Oversight (Contract laboratories, Distributors)
• Maintains the MC Quality Assurance (QA) Standard Operating  and all other documentation in EQV
• Manages coaching/training on GMP/GDP including QA documentation
• Assists with internal audits for GxP-related activities.
• Assist with audits by Health Authority or Global Quality Audit (GQA) group
• Business Continuity Plan
• Product Security
• Section 21 releases / pre-reg shipment
• Induction/Onboarding New Employees
• Continuous Improvement Plan
• Pack conversions
• Final Product Release for sale including all relevant processes in SA
• If this sounds appealing, please read on to understand the experience and skills we’re looking for…

ESSENTIAL SKILLS & EXPERIENCE REQUIRED

• Completed B.Pharm Degree and registration with SAPC
• 3 years plus experience of Quality Assurance in the pharmaceutical industry
• Solid understanding of the Good Manufacturing/Distribution Practice in the Quality environment
• Preference would be given to candidates with knowledge or experience in African Countries requirements
• Strong communication and influencing skills
• Coaching & Feedback – Leadership skills
• Attention to detail
• Problem Solving