Quality Assurance Supervisor
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JOB PURPOSE AND KEY RESPONSIBILITIES
- Implementation and maintenance of the Quality Management System in accordance with ISO 9001 and 13485 standards, and in compliance with the EU GMP and EU GDP Guidelines.
- Provide support to ensure compliance with local and regional legal requirements and regulatory authorities.
- Has responsibility and authority to maintain an adequate organizational structure within their respective facilities, departments, and/or functional group(s).
- Makes recommendations to RP/QP, Sr. Manager, Director, Global Healthcare Compliance.
- When delegated to do so by RP, decides on the final disposition of finished products, returned, rejected, recalled, or falsified products.
- Conducts Management Reviews, or ensures Management Reviews are conducted at defined intervals for Healthcare facilities/departments within their respective area of responsibility.
- To promote a “quality” culture within the company.
- To provide support for investigation into non-conformances and customer complaints.
- To approve changes related to the applicable facility.
- To follow-up on all Corrective Actions and Preventive Actions (CAPAs).
- To be focused on the management of the authorized activities and the accuracy of the records.
- To collaborate with the Qualified Person (QP)/Responsible Person (RP) to perform urgently all the operations during a pharmaceutical products recall.
- To ensure the customer complaints are managed efficiently.
- To ensure that customers and suppliers are approved.
- To participate and assist in supplier audits and provide evaluation of suppliers.
- To participate and follow up in Regulatory Compliance Reviews (RCR audits)
- To ensure the operations taken place in the warehouse are performed according to the approved SOPs and/or work instructions in accordance with ISO 13485 standards and in compliance with EU GMP and EU GDP guidelines.
- To follow up and control of the ambient conditions in order to ensure that the correct storage conditions for the products are maintained.
- To collaborate with the QP/RP with regards to transport temperature monitoring when applicable.
- Initiate/ attend Quality Management System Review meetings and present facility compliance metrics.
- To hosts audits and acts as an Inspection Coordinator for regulatory agency inspections.
- Monitor, conduct and coordinate self-inspections to ensure compliance with GMP, GDP andISO 9001 and 13485 requirements.
- To participate and follow up with client audits to identify issues and mutually agree on the solutions.
- To participates and follow up with agency audits to meet respective regulatory requirements.
- To review (and where applicable approves) policies, procedures, validation protocols, reports, work instructions, forms and regulations with internal/ external clients to determine specialized requirements and ensure compliance.
- To use existing career development process and tools with some assistance to monitor employee development; provides feedback to direct reports and peers on job skills and personal behavior; identifies employees’ areas of strength and developmental needs; recommends training opportunities for others with some guidance; assists in providing developmental suggestions to employees that align with their goals.
- To provide direction to the Facility/Department Healthcare Compliance (QA) Specialists.
- To oversee the tracking and reporting of required employee training for the facility/ department to ensure compliance.
- When delegated to do so by Healthcare Compliance (QA) Management, RP/QP, provide assistance in external audits
KNOWLEDGE AND EXPERIENCE
- Education level: Master’s Degree in Pharmacy.
- Good English in speaking and writing
- Good knowledge of Microsoft Office
- Experience with ISO 9001 standards and
- Experience with ISO 13485 standards is an advantage.
- Knowledge of GMP and/ or GDP guidelines is an advantage.
- Required minimum 4 years of experience in quality
- Good Communication skills to motivate team and to support internal/ external customer
- Good analytical skills.
- Good in People Management skills.
- Flexible in working hours.
- Ability to prioritize decisions which may have a significant risk for the company.
- Identify potential gaps in the processes and make recommendations for possible improvements.
- Identify and eliminate barriers to get an effective risk management and risk assessment.
- Initiation and Co-ordination of improvement projects throughout the company.
- Implementation of new processes having a quality critical impact on the business.
- Knowledge of electronic Quality Management System and/or Warehouse Management System (WMS, GWS etc.) is an advantage.
UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.