Quality Sys Spec I

Bio-Rad Laboratories, Inc; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Bio-Rad Laboratories, Inc. in Singapore seeks a Singapore Registered Pharmacist to support QA and regulatory activities at the distribution center.

You will help ensure compliance with ISO 9001, ISO 13485 and Singapore regulations, participate in internal audits, and drive continuous improvement in quality procedures. The role requires 1–2 years of related experience, a degree in Pharmacy, knowledge of QMS for medical devices, and preferred SAP familiarity.

Qualifications

• Singapore Registered Pharmacist.
• 1–2 years related experience or equivalent.
• Degree in Pharmacy or Bachelor of Science (Pharmacy).
• Knowledge of ISO 9001 & ISO 13485, preferably internal auditor trained.
• Korean language reading preferred.
• SAP knowledge preferred.
• Good understanding of QMS for medical devices and reagents.

Responsibilities

• Support ISO 13485:2016, ISO 9001:2015, SS620: 2016 or equivalent for Singapore Distribution Center (Asia Pacific and South East Asia).
• Support internal audits and identify gaps in compliance to drive corrective actions.
• Utilize critical thinking to root cause issues and implement improvements.
• Deviate from procedures appropriately based on knowledge of operations.
• Support regulatory activities including import/export licenses and controlled drug release as needed.

Skills

Knowledge of ISO 9001

ISO 13485

Korean language reading (preferred)

SAP knowledge (preferred)

Education

Degree in Pharmacy or Bachelor of Science (Pharmacy)

Tools

SAP

Job description

The successful incumbent will :

• Support ISO 13485:2016, ISO 9001:2015, SS620: 2016 or equivalent for Singapore Distribution Center (Asia Pacific and South East Asia)
• Support internal Audits
• Identifies gaps in compliance and takes necessary actions(s) to correct
• Utilizes critical thinking and problem solving skills in driving to root cause and corrective actions
• Can deviate from procedures based on knowledge of operations

How You’ll Make an Impact:

Quality Assurance Related Activities

• Ensures QMS programs meet objectives and comply with all applicable regulations and standards.
• Perform activities related to nonconformance, corrective actions and effectiveness checks.
• Works with operations personnel to continually improve quality procedures and methods.
• May perform activities related to one or more quality assurance functions including label QC activities, assisting with document inquiries and retrieval of archived documents and records, electronic records, SAP transactions related to Quality Notification.
• Issue corrective action reports based on internal/external audit findings.
• Assisted to communicate controlled documents (SOPs,WIs, Forms) to distribution centre/sales organization.

Regulatory Related Activities

• Support reporting of import and export license from Health Science Activities.
• Support ship hold and field safety support activities as required.
• Apply and maintains controlled drug licenses and execute operation control on the release of controlled drug products.
• Support export documentation such as coordinating of the Veterinary certificate and poison licenses to support distribution center operation.

Regulatory Surveillance Related Activities

• Prepares, maintains and updates library or external regulatory standards, reference and guidance documents.

What You Bring:

• Singapore Registered Pharmacist
• Minimum 1-2 years related experience or equivalent combination of education and experience.
• Degree in Pharmacy or Bachelor of Science (Pharmacy)
• Knowledge of ISO 9001 & ISO 13485, preferably ISO 13485 internal auditor trained
• Ability to read Korean is preferred
• Knowledge in SAP is preferred
• Good Understanding of Quality Management Systems (QMS) relating to medical devices and reagents will be an advantage

Who We Are:

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits:

Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and well-being of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, wellness programs, extensive learning and development opportunities and more.

EEO Statement:

Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation:

Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.