Quality Manager Malaysia

Education : EQUIVALENTEXPERIENCE

**As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.**

**Position Description**:
As the central Quality contact for the Elanco Marketing Affiliate organization (Malaysia & Indonesia), the QUALITY MANAGER advises, decides reports, consults and escalates quality matters relating to Elanco products distributed in Malaysia & Indonesia to the appropriate affiliate management, Sr. Manager Quality Malaysia & Indonesia, ASEAN Quality Director, APAC Senior Director Affiliate Quality or Corporate management when needed.

**Functions, Duties, Tasks**:
**CORE JOB TASKS**
- Be responsible for product quality related matters, escalate any local product quality related issue to the ASEAN Quality Director, APAC Senior Director Affiliate Quality and the affiliate management, and collaborate in any local action to be taken as a result of that (i.e. recall, counterfeit etc.)
- Implement and monitor product quality systems and Quality Manual in the Marketing affiliate.
- Assist affiliate management, ASEAN Quality Director and APAC Senior Director Affiliate Quality in assuring that all operations of the affiliate comply with the Affiliate Quality Manual and other applicable company quality standards and local regulations.
- Execute the assessment plan for GMP Service Providers.
- Create and revise Quality agreements covering affiliate processes for GMP service providers.
- Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective and preventative actions (CAPA), and use of a Quality Plan.

**SPECIFIC AREAS OF ACCOUNTABILITY / RESPONSIBILITY**

**1. Quality Management**
- Ensure affiliate compliance with Good Manufacturing Practices (cGMP) and Good Warehousing practices for finished products.
- Also ensure affiliate compliance with all relevant local regulations.
- Support Quarterly Quality Reviews
- Ensure an annual management review is conducted.
- Ensure Notification to Management within one day of identification.
- Halt, hold or quarantine product status as required.

**2. Quality Systems**

Batch Release
- Ensure products received comply with the market authorization, by approving/rejecting batches.

Change and Event Management
- Create, execute and close change controls that may affect the quality attributes of the product. Assist with management of the change control system.
- Create and resolve deviations (events) from normal procedures that could potentially impact safety, identity, strength and quality of the product. Ensure deviation completion is within requirements and corrective and preventative actions are completed by target date.
- Maintain local procedures which reflect local regulations (where required) and corresponding global quality standards.
- Create or review relevant quality related documents.
- Ensure record retention of documentation as per appropriate record retention period.

Personnel Qualifications
- Maintain a job description and career profile that describes the quality duties and review it every two years.
- Review, and approve GMP training material generated by the local affiliate and ensure training records are documented

Quality Plan
- Develop and execute the Quality plan as per internal requirements and local regulations as applicable
- Ensure compliance to the Affiliate Quality Manual, other applicable company quality standards and relevant local regulations by completing quality system maintenance activities by target due dates
- Adhere to and meet Quality plan actions target due dates.

Auditing and Inspections
- Conduct self-assessments of quality systems at least annually, to maintain a state of inspection readiness at the affiliate.
- Assess GMP suppliers and service providers where applicable according to an approved plan.
- Facilitate and co-ordinate Regulatory Agency inspections, EGQCA audits of the affiliate and service providers. Support the affiliate with the audit readiness plan. Take daily notes and report the daily audit activities to the affiliate Lead Team.
- Prepare written responses to EGQCA audits by consulting with the Senior Manager Quality Malaysia & Indonesia, ASEAN Quality Director and APAC Senior Director Affiliate Quality. Prepare written responses to regulatory agency inspections by consulting with the Senior Manager Quality Malaysia & Indonesia, ASEAN Quality Director, APAC Senior Director Affiliate Quality, Global Senior Quality Director and Director of EGQCA. Ensure timely responses and execution of actions by targe