Specialist Quality Assurance

Do you have expertise in Quality Assurance and a passion to play a critical role as the eyes and ears of our patients? If you have the passion and the drive to accelerate growth and make people’s lives better - then AstraZeneca is the place for you._

**ABOUT ASTRAZENECA**

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation 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.

At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim - treating, preventing, modifying and even curing complex diseases.

**What you’ll do**

Provides Quality Assurance support to an assigned area. Non-supervisory, provides advice in areas of processes and procedures. Role holder ensures efficient processes and procedures are maintained within the boundaries of regulatory compliance for relevant GxP.

**General Accountabilities**:

- ** Safety, Health and Environment**
- Work in a manner which promotes the safety and wellbeing of self, others and environment
- Contribute to improving SHE performance, proactively use STOP cards to identify SHE hazards and take appropriate actions
- ** GMP / Compliance and Ethical Conduct**
- Ensuring compliance of self and others to internal and external regulations
- Comply with all systems, processes, and procedures in line with statutory/ legislative / quality requirements.
- Understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.
- Optimising performance outcomes of self/direct reports and ensuring understanding of contribution within the organization.
- Ensure and monitor compliance self/QA team and third parties 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.
- 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.
- ** Quality Performance**:

- Aligning QA work schedule to consistently provide and supply high quality product.
- Participate in any discussion at site and/or regional level to maintain and/or improve Quality performance
- Actively participate to identify, develop, monitor, and maintain area Key Performance Indicators (KPI’s) as required. Take any action needed to prevent situations that may jeopardize the patient safety, quality of the product or supply to market.
- Builds productive and effective relationship with internal and external customers, such as other QA team and QC Lab, Manufacturing/Production, Engineering, Supply Chain & Logistic to ensure customer satisfaction and business success.

**QA Area Accountabilities**:

- ** Quality Compliance**:

- Ensuring the implementation of update Quality Management System/QCM/Global Procedure applicable to Cikarang Site operations, including in developing and maintaining SOP/Work Instruction in QA area and Site Master File
- Escalate to Management (i.e Quality Manager and/or Site Lead) any discrepancies (potential or real) during daily operations.
- ** Batch Record Issuance and Review**:

- Prepare BPR issuance as per production plan.
- Perform batch review before batch disposition by Qualified Person
- ** Document Management System & Document Control**:

- Manage Document Lifecycle in ECMS (effective, periodic review, withdrawal) in ECMS
- Ensuring adequate document control is in place, work closely with all system owner to ensure only valid document printed, distributed and used
- Coordinate paper-based Document Retention and Archival
- Oversight document retention and archival as per AZ Global Procedure/Requirement and Retention policy
- Oversight document destruction process activities as per applicable procedure
- ** Training Management**:

- Coordinate implementation of GMP Training Management i.e ensuring Job Description and Personnel Qualification Training program and its documentation are in place and keep updated by each respective line manager
- Developing and coordinating the execution of Annual GMP Training Program
- Support each respective line manager/system owner in tracking and ensuring training completion of relevant site personnel toward applicable SOP/Work Instruction
- Act as Cornerstone Training Administrator
- Managing the filing and arc