Quality Assurance Executive

**Duties & Responsibilities**
- **Responsible for managing Deviation Management System & CAPA Management to ensure c **ompliance with Quality Assurance Procedure and Regulations**
- Maintain the Deviation Management system, including assisting with investigations, review and approval of completed investigations and insuring CAPAs are appropriate and effective for Non-Related Batch
- Coordinated with related department to follow up on time implementation of corrective and preventive actions & Effectiveness Review (ER) Evaluation of CAPA
- Update progress of corrective and preventive actions implementation regularly
- Prepare trending report of deviation and CAPA annually
- Coordinate with related department to perform gap analysis of global quality document related to deviation/event, CAPA, etc compare to local SOP and coordinate execution of CAPA required
- **Responsible of Quality Management of third parties **to ensure c **ompliance with Quality Assurance Procedure and Regulations**
- Management of subcontractors
- Supplier or vendor audits, qualification, approval, certification
- Quality agreement /QSMP approval.
- Owner/Author of Approved Supplier List (AVL) including revision regularly
- Collaborate with QS Executive to perform gap analysis of global quality document related to Quality Management Third Party compare to local SOP and revise local SOP if required
- **Responsible for managing counterfeit product **to ensure c **ompliance with Quality Assurance Procedure and Regulations**
- Conduct investigation for suspect counterfeit products
- Provide induction training for new employees related to Anti Counterfeit Drugs
- **Coordinate Quality Assurance activities to ensure compliance with quality assurance procedure and regulations**:

- Provide Periodic Monitoring Report (i.e.
temperature, water & particle) as schedule
- Compiling / numbering and filing risk management report & create CAPAs regarding the risk management report
- Contribute in quality and performance continuous improvement program and ensure the program execution as per timeline agreed
- Contributing to ensure site is ready to be inspected by any regulatory inspection at anytime
- Perform evaluation of Product Quality Review (PQR) on yearly basis
- Perform mock-up recall annually (if there is no recall)
- Actively involved in continuous improvement program
- Implement HSE practice in area of work
- Support or can be assigned as quality related project coordinator

**Knowledge, Skills & Competencies / Language**

Technical Skill & Competencies/Language
- Technical Equipment Know How on QA
- Basic competency on English

Behavioral Competencies

Core Competencies:

- Strive for result (exceed standard performance)
- Act for change (participating in change)
- Corporate transversally (leverage teamwork)
- Commit to customer (take responsibility to fulfill customer needs)

General Competencies:

- Continuous Learning (Practical & Actual Learning).
- Analytical Thinking (Break Down Issues).
- Committed To Org.
Ethic (Act With Integrity)
- Communication (Clear Message).
- Adm, Record, Data Handling, Planning & Organizing (Reporting & Administration Understanding).
**Qualifications**:

- Fresh graduate or at least 1 year working experiences in quality manufacturing area in pharmacy industry
- Bachelor's degree in Pharmacist/Engineering major is a must

**Requirements **of the job**:

- Possess knowledge of GMP (Good Manufacturing Practice) is a must
- Ability to work with all level blue-collar and white-collar employee
- Experience working collaboratively in matrix structure
- Performance focused mind-set
- Proactive and displays urgency to meet business needs
- Detail, process oriented and performance focus
- Demonstrated and recognized capacity to perform analytical thinking and pragmatic approach
- Good communication skills in English
- Aptitude for transversal collaboration and teamwork
- Good knowledge on Microsoft excel, Microsoft word and Microsoft power point

Li-SEA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values.
We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.