• Role : Deputy General ManagerR&D Quality

• Job Location : Vadodara (Preferred) OR Gurugram

• No. of Direct Reports : 5 (Team size: 25)

• Experience: 20+ years of experience

Job Summary:

This position leads and directs R&D qualitys sub team responsible to Implement, review and monitor the R&D quality systems applicable to GxP and Development areas of Analytical Research & Development at SUN Pharma, Gurugram and Vadodara R&D sites

Must have skills:

• 10 years of experience in QC - Should have faced regulatory inspections under USFDA and 10 years of experience in Analytical method validation and experience in addressing regulatory queries

• Quality assurance, GMP Practice experience, Plant QC & Development knowledge.

• Development & validation: Regulatory filing, method validation, characterization, QC testing, method transfer

• GMP activities: Regulatory GMP experience,Adequacy of method validation and accuracy

Areas of Responsibility:

• Provide QA Oversight during the Analytical method development, verification, validation and Method transfer of API and Drug product test methods.

• Ensures Quality programs required for Analytical R&Ds GxP Labs and Development Laboratory are established and maintained to meet regulatory and Suns global standards.

• Lead the team in managing regulatory inspections at GxP departments and ensure all-time readiness for successful regulatory inspections.

• Support method transfers to manufacturing sites in line with Corporate Quality policies.

• Review and verify scientific rigor, adequacy, and completeness of analytical documents like characterization reports, Test procedures, specifications, CoAs, Protocols and its reports, intended for the regulatory filing.

• Review and Approval of R&D QMS (SOP, Change control, Deviation, CAPA, Lab events) for completeness and compliance.

• Review and approve computer systems and its deliverables to meet 21CFR Part 11 requirements.

• Plan and execute internal audit program for the GxP Labs and Analytical Development Lab

• Support in the Qualification audit and approval of new vendors like Contract testing labs and contract service providers used for the development activities.

• Implementation Support quality & regulatory compliance programs

• Problem Solving: Facilitate root cause identification and work out solutions.

• Team Management: Set team goals, objectives, and strategic direction in alignment with Global Quality Assurance and R&D Quality goals. Provide resources within the team to build improved technical and management skills, including decision-making, handling of quality exceptions, planning, etc.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.