This job is currently Archived,
Quality Assurance Manager CMO - Russia
Posted on : 13 May 2017
- This position is responsible for setting up, implementing and maintaining the quality system for the Russia commercial affiliate (concerning the CMO operations) that supports compliance with pharmaceutical regulatory requirements.
- To assure that the contract and licensing manufacturing operations, comply with relevant company policies, with Good Manufacturing Practices (where applicable), with the QA agreement, and with local regulatory requirements.
- To ensure QA oversight of local CMO’s within company vendor team.
- To provide QA expertise for the consolidated supply chain to ensure Marketed Products are controlled in accordance with 61-FL and other applicable regulatory requirements.
- To effectively partner with Supply Chain Operations and Commercial groups, Project Teams, other Global Quality Assurance groups and Operational Quality Assurance teams.
- Be a source of technical expertise in the manufacture and testing of Pharmaceutical Product for Russia commercial Affiliate
- Participate in Vendor Risk assessment within the vendor team
- Investing/approving devitiations/complaints generated from CMOs
- Review/approve change control from CMOs
Build, operate and maintain key elements of a pharmaceutical quality system fit for purpose and aligned to national and international regulations and to the Global Quality Standards (policies and local/corporate/global SOPs)
- Manage the development, implementation and maintenance of an effective and efficient quality system
- Implement and maintain the QA agreement between the CMO and the company
- Manage the development and implementation of appropriate local SOPs CMO related
- Maintain a state of compliance with national and international regulatory requirements and with policies and applicable local, corporate and global procedures
- Manage locally any recalls of CMO drug products and liaise with Global Quality Assurance affiliates team
- Ensure the management of product complaints coming from the local market relevant to CMOs 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 at CMOs
- Deal with regulatory agency inspections and organise and coordinate pre- and post-inspection audits as required; lead affiliate preparation and coordinate audit activities with global team members relevant to CMOs
- To interface between the local market, Global support and CMOs
- To contribute to the business objectives by assuring quality of the products within the distribution chain of CMOs
Manage CMOs activities and assess quality impact whenever deviations, change request or incidents are issued by the CMOs.
- Ensure that Quality Agreements are in place to cover the business relationships
- Review and approve on company's behalf batch records, deviations, change controls, stabilities, audit follow-up, APRs, QA indicators, validation protocols and reports, variations implementation and GMP agreement updates and enforcement
- Minimum 3 years’ experience in the pharmaceutical regulated environment primarily in Quality Assurance
- Experience in pharmaceutical manufacturing of dry formulations is an asset
- Must be knowledgeable in regulatory and technical requirements of the pharmaceutical industry, have interacted directly with regulatory agencies, and have a strong Pharmaceutical background
- A comprehensive understanding of current regulatory requirements and ability to interpret current regulations is required
- Experience in audits and regulatory inspections
- QA/compliance experience in quality systems. Areas of expertise should include regulatory affairs and compliance, quality assurance and controls, validation and technical services.
Job Segment: Law, CAPA, Supply Chain Manager, Pharmaceutical, Quality, Legal, Management, Operations, Science