Quality Assurance Manager CMO - Russia
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- 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
- 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
- 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.
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