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Quality Operations Manager – ExM
Teva Pharmaceuticals3rd Party Quality Operations Manager responsible for quality compliance in pharmaceutical production. Overseeing product lifecycle and supplier management in Sofia, Bulgaria.
About the role
Key responsibilities & impact- guarantee that current pharmaceutical standards, legal regulations and approved registrations are implemented
- Supervise the entrusted products through the entire life cycle with regard to pharmaceutical quality
- Act as an internal and external contact person for all issues concerning the pharmaceutical quality of third party manufactured products
- Coordination and controlling of all GMP relevant documents with regard to manufacturing process, quality control and quality assurance
- Support/perform the initiation, coordination and evaluation of new product introductions and product changes
- Maintain the regulatory compliance of suppliers with EMA authorities
- Review and Authorize Master Documents to assure regulatory compliance on the supplier’s level
- Support the negotiation, preparation and approval of new QTA’s
- Support preparation and execution of regular audits/technical visits to the entrusted vendors
- Support the initiation & Oversight on PQRs for medicinal products manufactured by 3rd parties
- Support the necessary investigation and closure of deviations
Requirements
What you’ll need- Bachelor’s degree in Pharmaceutical/Natural/Engineering science or related field
- 3+ years’ experience in quality control / analysis, production and / or quality assurance
- Must have working knowledge of cGMPs and applicable international regulations/guidelines
- Strong computer skills including MS Office, TrackWise and SAP
- Good communication skills and resilience
- Good command of the written and spoken English language
Benefits
Comp & perks- generous annual leave
- reward plans
- flexible working schedules (dependent on role)
- access to tailored health support
- meaningful ways to give back to the community
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality controlquality assurancecGMPregulatory complianceproduct introductiondocument reviewdeviation investigationpharmaceutical qualityproduct life cycletechnical audits
Soft Skills
communicationresilience