Head - Corporate Quality Assurance (15-25 yrs)

Role: Head- Corporate Quality Assurance

Designation : General Manager

Experience : 15 to 20 years of experience

Location: Navi Mumbai - Turbhe.

Reporting : CTO

Team : 4 Direct Reporting | Team Size : 15 members.

Qualification : M.Pharm / B.Pharm /Master's in science

ROW | SAHPRA Experience Preferred

Job Details :

JOB RESPONSIBILITIES:

- Establish best-in-class quality goals, perform quality metrics trending, apply problem solving, system improvements to meet these target levels of quality.

- Lead and manage the quality teams with oversight in operations at all manufacturing facilities with a continuous improvement focus.

- Team Building. Establish, inspire, train, mentor and manage a team of QA professionals in the adoption of new processes and tools.

- Collaborates with Business Units to develop quality targets for new and existing products.

- Manage quality projects/activities resulting from site consolidations, acquisitions.

- Collaborate with Quality Management System group on simplification, harmonization of quality systems and implementation across Operating Companies.

- Manages and maintains effectiveness of Quality System across all company's manufacturing sites and Contract Manufacturing site.

- Implementation and follow effective Vendor / Supplier development process.

- Maintains compliance to Global Quality Management System

- Drives recruitment activity and assures the ongoing professional development of direct reports and the overall company quality organization.

- Establishes standards/metrics to facilitate exponential growth while adhering to quality standards and
regulatory guidelines.

- Participate and contribute to regular functional meetings (Supply Chain, Operational Excellence, and Sourcing, R&D)

- Responsible for QA teams in a group of global sites. The QA teams are responsible for Audit management, Document control, Deviation, Change Control, CAPAs, Complaints, Adverse eventreporting, final product release, and other QA related activities.

- Promotes customer centric, proactively seeking ways to improve customer satisfaction.

- Use CAPA system to systematically improve processes and organization capabilities.

- Makes sure that sites are prepared of Regulatory Agency Inspections. (Pre-Approval Inspections /Mock inspections and Training).

- Quality lead in the due diligence, transition, and integration in an acquisition project.

- Participates in the planning, review and approval of GMP /GDP related issues of new or remodeled facility layouts, including validation activities.

- Providing and participating in trainings efforts of companies sites on need basis

- Advice and support alliance partners/service providers/central distribution center to ensure complianceto Quality requirements

- Gives immediate support in the form of possible corrective actions during the audit and Compliance.