Senior Specialist, RAQA

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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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Explore this location B-21-3A, Level 21 , The Ascent, Paradigm , No. 1
Jalan SS 7/26A Kelana Jaya
47301 Petaling Jaya, Selangor
Malaysia Explore This Location

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