Senior Specialist External Quality

Typical Accountabilities:

• The position is responsible for QA activities that support the execution of Quality Management of Suppliers with regard to Distribution. This includes quality system management and supplier performance management for the following activities: QA audits, supplier risk assessment, supplier data maintenance, change control, distribution-related quality complaints and deviation investigations, quality issue management and escalation, pack conversions, QA Agreements (establishment and maintenance) between AZ and External Suppliers. This position requires strong cross-functional ways of working with non-QA members in the team.

• This position plays a key role as part of the Quality Assurance Team in the AZ Market Company, with responsibilities including but not limited to logistics quality oversight and supplier management.

• This position requires strong cross-functional ways of working with other stakeholders, including but not limited to AZ ASIAPAC Logistics Functions, AZ sites, and AZ marketing companies.

• In addition, the position will also act as the QA leader on new supplier introductions, projects, process optimization within ASIAPAC Distribution.

• The position should support the preparation for and management of Health Authority inspections at External Suppliers, AZ Sites and AZ Marketing Companies.

• At the highest level, this position provides quality advice to Distribution team members, working closely with the Distribution Managers (DM) and supporting QA and cross-functional team members during issue resolution to ensure that there is no delay in product launch or supply caused by responsible quality activities.

• The position should perform GDP and GSP regulations assessments incl. risk mitigation actions to ensure quality compliance in responsible area

• Perform supplier quality management according to AZ standards/SOPs/Work Instructions/applicable guidances and local GSP regulations

• Collaborates with and influences other Quality professionals within AZ Business Process Networks to ensure consistent application and execution of key quality systems

• Actively participates in quality management reviews to present quality KPIs and lead issue resolutions in the responsible area.

• Accountable for QA decision-making on responsible issues; works directly with the QA lead and other LT members to deliver objectives

• Ensures ASIAPAC distribution organization complies with all GDP and local GSP requirements by providing effective coaching, mentoring, and consultation to the distribution organization.

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to the role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

• Ensure and monitor the compliance of suppliers by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.

• Draft and/or approve QMS procedures relevant to distribution for the China trading company, if required by the line manager.

• Oversight 3PL in drug inspection and drug traceability system setup

• Deliver quality trainings to distribution teams or 3PL if needed

Education, Qualifications, Skills and Experience

Essential

• Bachelors degree in Pharmacy, Biology, Chemistry or related area. 

• At least 5 years experience in GDP/GSP quality role in the pharmaceutical industry

• English oral and written communication skills

• Strong ability and motivation to learn

• Experience in 3PL quality management

• Ability to travel nationally and internationally as required approximately 20% of their time.

• GSP company working background is a must, while licensed pharmacist is preferred.

Desirable

• Experience in interations with health authorities in the GSP area.

• Multi-site / multi-functional experience

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.