Contract & Working Conditions
- Permanent contract
- Working hours: Monday to Friday, 8:30 AM – 5:30 PM.
- Hybrid working model
Job Description
This position monitors the overall Quality System status of the distribution center and ensures compliance with drug, medical device, food supplements and local regulations. The role supports the maintenance of quality processes through the implementation of procedures, training, audit, CAPA and change control.
Responsibilities
- Ensure all staff are trained in their respective job functions, including GDP/GMP requirements.
- Draft and revise Standard Operating Procedures as needed.
- Conduct regular inspections of the facility and recordkeeping, summarizing and reporting findings; coordinate or support corrective and preventive actions (CAPA).
- Communicate with clients and provide support during external audits.
- Liaise with Regulatoy Agency officials during regulatory audits.
- Provide guidance and support on Customer/Client QA-related questions and concerns.
- Monitor departmental processes and systems to ensure regulatory compliance and operational effectiveness.
- Investigate discrepancies and issues, escalating findings to the appropriate stakeholders.
- Support the development of proactive strategies to mitigate potential future risks within systems or processes.
- Complete NCR reports and manage change control requests, ensuring appropriate follow-up.
- Support the maintenance, continuous improvement, and effectiveness of Quality Systems.
Qualifications
- Experience in pharmaceutical, healthcare, or food industries preferred.
- Previous experience in Quality Assurance is considered a plus.
- QP or RP certification is a plus
- Bachelor’s degree in Pharmacy, CTF, Biology or related field (or internationally comparable).
- Be eligible to obtain RP/QP designation is a plus; prior certification is not required.
- Risk Analysis with FMEA tool is consider a plus
Employee Type
Permanent
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