Quality Assurance Executive

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

At Roche Pharma Malaysia, we are seeking a Quality Assurance Specialist to play a crucial role in ensuring the highest standards of quality throughout our operations. This role is reporting to Quality Assurance Lead.

By overseeing batch release, managing local redressing activities, handling returns and write-offs, and resolving quality-related complaints, you will contribute to our mission of delivering safe and effective pharmaceutical products to our customers.

Your commitment to maintaining compliance with regulatory systems and driving continuous improvement will enhance our reputation as a trusted provider of high-quality medications.

Through collaboration with third-party providers, meticulous data entry, and efficient file management, you will contribute to the seamless execution of our regulatory activities and ensure accurate product information updates.

As the owner of SOPs, you will have a direct impact on our processes, promoting consistency and excellence in our operations.

With your decision-making authority, you will play a critical role in upholding our commitment to quality in all aspects of our work.

Join us in this impactful role and help us make a difference in the lives of patients.

As qualified Quality Assurance Compliance and Operations, you will:

• Responsible for quality assurance operational activities including managing batch release activities for incoming shipments, local redressing activities, trade returns and write offs, quality related complaints or enquiries and product recall. Work closely with appointed third party service providers and resolve any operational related issues in a timely manner.  

• Responsible for maintaining compliance to the Pharmaceutical Management System (PQS) and Regulatory Compliance System, and supporting compliance activities by driving innovation and continuous improvement.

Information and Documentation Management:

• Ensure accurate, timely and thorough data entry for Affiliate regulatory activities on relevant Roche systems.

• Manage product information updates with respect to Roche and local regulatory requirements and for Roche databases.

• Ensure files are managed properly and archive documents are complete and easily retrieved.

• Good housekeeping of Quality Assurance areas and inventory, including Filing Rooms.

• Responsible and accountable to ensure SOP is updated as per required on a timely manner

• Clearance from Quality Assurance Lead is required for all matters related to quality matters, except routine on-going activities.

Expertise:

• Experience in a Quality Assurance role in a pharmaceutical environment for 1-3 years is a plus

• Knowledgeable in GxP requirements, in particular, GMP, GDP and GDPMD.

• Fluency in written and spoken English and Bahasa Malaysia.

• Proficient in basic computer software/applications

Competencies & Education / Qualifications:

• Demonstrate Roche Core Competencies.

• Integrity

• Good analytical, problem-solving and decision making skills

• Detailed-oriented with a focus on accuracy and precision

• Builds truthful and effective relationships with stakeholders.

• Commitment to performance measures of time, cost and quality.

• Communication Skills: strong interpersonal skills to influence individuals or groups at more than one level who may have different interests or goals to reach consensus and achieve team objectives. 

• Takes responsibility, drives results and achieves expected outcomes.

• Degree in chemistry or science-related field.

• Trained in GMP, GDP and GDPMD requirements for pharmaceuticals and medical devices.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.