Transforming challenges into opportunity. Accelerating careers. Propelling business growth. Few companies can match Experis’ scope, history of success and our reputation as the global leader in professional talent and solutions. We know that peak performance is humanly possible. We help our clients and our talent to achieve it through our deep industry knowledge and an unmatched understanding of human potential.
Experis accelerates business growth and careers by intensely attracting, assessing and placing specialized expertise in Information Technology, Engineering, Manufacturing, Healthcare and other industries. We precisely deliver in-demand talent for mission-critical positions, enhancing the competitiveness of the organizations and people we serve. We also apply our expertise to provide a suite of proven workforce solutions that improve our clients' productivity, efficiency and cost containment.
Experis is a dedicated business unit of ManpowerGroup – a world leader in employment services for nearly 70 years, and a recognized pioneer in the industry.
Senior QA Specialist / 12 Months Contract/Pharmaceutical Industry
jobsDB Ref. JSG400003003027522
EA License No 02C3423
- Provide functional support to the Affiliate Quality organization to ensure that business and quality objectives are met.
- Develop and implement sound quality principles at the affiliate while minimizing disruptions to business, based on a robust quality risk assessment.
- Communicate with internal and external customers on all quality and compliance-related matters.
- Development, manage and implement quality principles to ensure effective compliance of the affiliate quality system with policies, processes and procedures and all applicable regulations and industry standards, including establishment and maintenance of local procedures, work instructions, records and all applicable quality system documents
- Investigate quality events such as deviations, nonconformities, complaints and corresponding action plans.
- Manage the affiliate label finishing activities (e.g. redressing) to ensure compliance with requirements and minimize risk.
- Monitor physician sample handling.
- Manage internal and external quality inspections and audits (including reporting, response to observations and tracking of action plans).
- Management of GXP supplier qualification program for the affiliate including audits, quality agreements and performance monitoring.
- Quality management of medical devices (e.g. vaporizers)
- Coordinate change control process to ensure changes do not introduce negative impact to operations.
- Coordinate and support of all activities related to market actions (recalls, withdrawals, corrections, etc.) in the affiliate in collaboration with affiliate Regulatory Affairs and General Manager.
- Coordinate the management review process for the affiliate.
- Coordinate quality training program; develop and implement quality system training to ensure compliance with identified quality goals, standards and in line with quality policies and procedures.
- Responsible for establishing and carrying out a quality self-inspection program within the affiliate.
- Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature shipments.
Bachelor degree in Pharmacy, Chemistry, Biology or related Science/Technical field
2-5 years of work experience with quality assurance systems and regulations in the Pharmaceutical or related industry.
Knowledge of local and international Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).