Manager Quality Operations (Artwork)

Job description

Job Description

Manage all operations and activities within the responsible service area of Quality Operations to ensure PLS-M&SO delivery is in compliance with customer requirements, cGMP regulatory requirements and the Novartis Pharma Quality Manual & Policies.

• Direct, oversee and coordinate all activities related to Pharma Artwork service delivery within Quality Operations service group. • Select, recruit, develop, manage, coach, coordinate and appraise the performance of direct reporting associates and ensure high quality performance management across the team. • Coordinate with Team Lead/ Sr. Team Lead-Quality Operations (Artwork) to ensure efficient and transparent allocation of resources to assignment of activities in support of service deliverables. • Author, review and approve GxP documents and reports like trends, performance, qualification, validation, quality events and technical investigations. • Hold and manage key accounts in Artwork workflow applications (like ArtBase, AQWA Art etc.) to ensure appropriate execution of service deliverables. • Generate and analyze predefined and ad-hoc reports in various applications and perform follow-up actions if required. • Ensure compliance of the responsible service area to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements. • Support, monitors and reports on process, data and system integrity & performance, in order to proactively drive, together with Team Lead/ Sr. Team Lead-Quality Operations (Artwork), adherence to the defined process within the organization, as well as to achieve excellence in the process and system. • Lead new service or expansion projects and transitions, monitor and report progress and deviations, as appropriate. • Work together with Team Lead/ Sr. Team Lead-Quality Operations and customers to ensure they are kept regularly informed of issues related to the service delivery and elaborate risk mitigation plans, as appropriate. • Act as escalation contact point for customers and team members for any GxP or non-GxP issues and lead related investigations to ensure compliance with local and global operating procedures.
Position Title

Manager Quality Operations (Artwork)

Desired profile

Minimum requirements

Graduate / Post Graduate in Engineering/Pharmacy/ Science or related fields • English Overall 10+ years of experience in Pharma Artwork, Labeling, Packaging or related field with minimum 2 years of hand on working experience in Artwork creation and change control. Exposure to working in GxP environment is preferred.
Job Type

Full Time
Country

India
Work Location

Hyderabad
Functional Area

Technical Operations
Division

NBS
Business Unit

PLS NBS
Employment Type

Regular
Company/Legal Entity

Nov Hltcr Shared Services Ind