Quality Assurance Professional with Expertise in Pharmaceutical Regulations
hace 12 horas
Company Overview
Takeda, a leading global pharmaceutical company, is seeking an experienced Quality Assurance professional to join its team. The ideal candidate will have a strong background in quality management and regulatory compliance within the pharmaceutical industry.
Estimated Salary: $85,000 - $110,000 per year, depending on location and experience.
About the Role
The Senior Quality Specialist will be responsible for ensuring that all quality-related activities are conducted in accordance with Takeda's policies and procedures, as well as relevant local and international regulations. This includes implementing and maintaining a quality management system that meets the Guidelines on Good Distribution Practice for medicinal products for human use (2013 / C 343 / 01), ISO 14001 requirements (in the case of TFE), and local legislations.
- Quality oversight of outsourced distribution partners
- Ensure compliance with legal and corporate requirements, as well as I-SOPs and Local SOPs
- Establish corrective and preventive actions and promote continuous improvement in critical processes from a quality perspective
- Local quality surveillance connects with customers: Returns, market actions, complaints, inquiries
- Maintain good relationships with the Local MOH for Good Distribution Practices inspections and work closely with RA in MOH communications
- Support geographic expansions and brand plan launches
- Shipping validation and distribution processes quality oversight
- Contribute to the identification of risks in the quality area, CAPA proposal, and follow-up
- Interact with Local Stakeholders: Supply Chain & Customer service, Customers, Pharmacovigilance, Regulatory Affairs, Compliance, Suppliers, Medical Affairs, Marketing
Key Responsibilities
The Senior Quality Specialist will be responsible for the following key areas:
- Batch release documentation of the company products to ensure quality, including incidences and complaints solving
- Training activities in the quality area and management of staff training records for GxP positions
- Change Control & CAPA management and monitoring
- Management Review Systems and Quality Council meetings
- Collaboration in QMS maintenance
- Handling of returns and management of returned products
- Control of damaged and broken products
- Local Complaint Coordinator & management of counterfeit products
- Resolve technical requests regarding products: storage, manipulation, expiry, and administration
- Responsible for Annual Environmental Declarations
- Control of free samples distribution and storage in accordance with national law
- Supplier approval and maintenance
- Ensure timely delivery of fully compliant products applicable to local regulations
- Control of narcotics / controlled substances according to National legislation
- Participation in internal and external audits and collaboration with CAPA plans follow-up
- Management of enquiries related to the technical / quality department
- SOPs & Document management, collaboration in Global procedures implementation at the local level
- Promote Takeda-ism philosophy and values
- Communicate adverse reactions to the pharmacovigilance department
Requirements
To be successful in this role, the candidate must have:
- Bachelor's Degree in Pharmacy
- Practical experience of at least 6 years in the Pharmaceutical Industry, primarily in a QA environment
What You Bring to Takeda
The successful candidate will bring a strong background in quality assurance and regulatory compliance, excellent communication skills, and the ability to work collaboratively in a fast-paced environment. They will also be passionate about promoting Takeda's philosophy and values.
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