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QA and PV Manager (Quality Assurance and Pharmacovigilance) - Russia
Posted on : 13 May 2017
- QA contact for the organization
- Implementation of the Affiliate quality management system meeting company requirements and local regulations
- Support of testing of Pharmaceutical Product
- Investing/approving devitiations/complaints
- Support Recalls
- Review/approve change control
- Review/approve SOPs
- Review/arrange signing of QAA
- TrackWise implementation
- Manage the development, implementation and maintenance of an effective and efficient Affiliate quality system.
- Implement and maintain the QA agreement (ensure inter-site quality agreement with Global QA and associate appendices are complete and up to date).
- Manage the development and implementation of appropriate local SOPs
- Maintain a state of compliance with national and international regulatory requirements and with policies and applicable local, corporate and global procedures
- Drive the periodic review and evaluation of the affiliate quality systems and procedures to assure consistency with pertinent national and international regulations and with the company standards.
- Monitoring and assessing quality systems by means of audit and self-inspection, and other forms of evaluation against company and regulatory standards.
- Manage locally any recalls of drug products and liaise with Global Quality Assurance affiliates team.
- Manage change controls according to local, corporate and global procedures
- Manage product complaints coming from the local market is compliant with quality standards.
- Define, review and participate in risks assessments, investigations or corrective and preventive actions (CAPA) of product complaints, failures, recalls, withdrawals and quality related problems, timely follow up and closure on all relevant complaints, deviations and CAPAs.
- Deal with regulatory agency inspections and organise and coordinate inspection and audits as required; participate in affiliate preparation and coordinate audit activities with global team members.
- Manage Archiving system for GxP documents.
- Support Global projects on quality systems as needed.
Education and Experience
- Degree in Pharmacy, Chemistry, Chemical Technology, Medicine or Biology.
- Minimum of 3 years working in the pharmaceutical industry in a quality management position.
- Experience interacting with regulatory bodies and third party organisations with respect to QA systems and regulatory inspection preparedness.
- Auditing expertise is an advantage.
- Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations.
- Must be able to effectively interact with and influence internal and external personnel management on many aspects of project and product and quality related matters.
- Must be an effective team player.
- Must possess excellent interpersonal, verbal and written communication skills at all levels internally and externally (Intermediate English).
- Must be able to understand, analyze, and summarize scientific medical information.
- Must have the ability to independently analyze data and information to draw conclusions and make effective decisions.
- Must have ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way.
- Must be able to develop innovative solutions through judgment and reasoning leveraged from extensive quality experience.
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