Senior Specialist, RAQA

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At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

Summary

Under limited supervision responsible for the local implementation of regulatory and quality activities and strategies obtain and maintain marketing authorizations for product(s) and communication of local regulatory requirements in support of licensing of drugs biologics and medical devices products.

Essential Duties & Responsibilities

• Strong experience in drugs and biologics
• Relevant experience in medical devices in Malaysia
• With direction develop and execute regulatory project plans
• Identify and elevate key areas of regulatory risk
• Maintain awareness of regulatory requirements; identify relevant requirements
• Participate as an active team member and provide regulatory advice to project teams as required
• Respond to questions from regulatory authorities within strict timelines
• Compile and submit in a timely manner regulatory documents according to regulatory requirements
• Maintain and update existing regulatory authorizations
• Support regulatory activities relating to specific portfolio of products/projects
• Prepare review and approve labeling and review AdProm materials for compliance with local regulations
• Prepare SOPs to reflect specific local requirements.
• Represent or lead Regulatory Affairs in small project teams
• Provide guidance to junior team members when needed
• Perform other duties as assigned

For QA responsibilities

• Appoint as designated person /QMR for GDPMD
• Responsible for product complaint related matter/non-conformances/product recalls/FAs and ensure procedure compliance.
• Responsible for the completion of Product Complaint reporting to ensure notification to Complaint Coordinator within required timeframe and investigation of returned samples to determine root cause.
• Immediate follow-up of potential Medical or Adverse Event product complaints according to corporate requirements.
• Report follow-up and trend product complaints.
• Responsible for FA related actions viz. customer notification letters regulatory reporting and product recall activities.
• Reply to customer complaint queries related to quality presentation to customer on quality.
• Responsible for release of Finished Goods with temperature controlled and after routine redressing.
• Responsible for redressing instruction.
• Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
• Oversee documentation to ensure completion of records and GDP Compliance
• Prepares SOP Document Change Request (DCRs) and Periodic Review.
• Ensure compliance with SOPs quality assurance internal and local regulations and GDPMDS (GDP for Medical Devices) standards.
• Internal external and supplier audit management
• Responsible for managing suppliers with the support of supplier quality function.
• Assist with data gathering and analysis for Quality Reviews/Complaint to ensure occurs at required frequency.

Education & Experience

• Degree in pharmacy science or related discipline is an advantage
• At least 5 years of relevant experience in pharmaceutical biologics and medical devices in Malaysia
• Regulatory and quality experience (within a healthcare environment
• Pharmacist License is an advantage
• Well-versed with new registration license extensions variations and renewals in Malaysia. Experience with both drugs and medical device registration is an advantage.
• Knowledge of applicable regulatory laws and acts and well-versed with changing scope and evolving regulations
• Knowledge of regulations and well-versed with changing scope and evolving regulations
• Good understanding of GDPMD
• Project management skills
• Manage multiple projects and deadlines
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Negotiation skills
• Technical system skills (e.g. word processing spreadsheets databases online research)
• Ability to identify compliance risks and escalate when necessary

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

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