Job expirat
Join a global market leader in the pharmaceutical industry in Romania. This is a new position in a big pharmaceutical company for a Quality Assurance Manager, offering a great opportunity for anyone willing to bring their career to the next level.
Tasks & Responsibilities:
-You would review customer feedbacks and trends in quality of service delivery.
-You would ensure that the processes needed for the quality management system are established, implemented and maintained.
-You would conduct audits of the quality system and operations according to the audit plans.
-You would liaise with external auditors/Inspectors for organizing audits
-You would review reports and project deliverables before issue (sample basis).
-You would administer and maintain the quality documents and records including SOPs or other quality documents received by external clients.
-You would review and document QA approval of SOPs before issue.
-You would ensure the promotion of awareness of customer requirements throughout the organization.
-You would advise and prepare strategic audit plans of internal audits to cover the main operation and ensure that the planned audits are conducted and reported.
-You would report to top management on the performance of the quality management system and needs for improvement.
-You would conduct a regular review of implementation of corrective and preventive actions derived from internal or external audits (or other notification related to quality issues) until closure.
Requirements:
-University degree in life sciences or equivalent.
- Relevant experience in clinical QA within pharmaceutical/biotechnology industries.
-Knowledge of clinical research and GCP requirements
-Continuous development into current regulations, guidelines and industry standards.
-Excellent interpersonal and communication skills, self-motivated, clear thinker
-Ability to plan and organize work, to work under pressure with high attention to detail, to independently evaluate and communicate development needs.
Hays Pharma is a leading global pharmaceutical and biotech staffing business that provides mid to upper level staff involved in drug discovery, clinical development, post-approval services and commercial activities.