Assistant Manager, QualAssr-ARPL-AQAQ AR

Job Summary

Responsible for effective review and approval of Change controls/ Laboratory investigation reports/  Deviations / Lab events/ Corrective action and preventive action (CAPA’s).

Job Responsibilities

• Review and approval of lab investigation reports (LIR), Deviations, Questionable results, Out of specification (OOS) and Out of trend (OOT) investigations.
• Preparation and review of Standard operating procedures.
• Review and approval of lab events and Temporary changes.
• To review laboratory data with respect to investigations.
• Co-ordinating with cross functional team for the closure of investigations in timely manner.
• Responsible for review and approval in various stages of change controls like QA Acceptance, Change control assessment, QA summary, M-Doc approvals, action item verification & Final closure.
• Co-ordination with regulatory department for regulatory submisssions/Post approval changes.
• Review and approval of CAPA.
• Review of LIR trend reports.
• Responsible for approval of Specification/Certificate of analysis and method of analysis.
• Support to regulatory and customer audits.
• Identify system improvement opportunities for process efficiency.
• Work both independent & as a part of intra/inter departmental teams to ensure that all work is completed in a timely manner to meet compliance.
• Ensure to respond immediately on queries from cross functional teams.
• Approval of reports wherever applicable.
• Work as a member of a team to achieve all outcomes.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Minimum MSc/B. Pharm degree or any equivalent degree.

• Experience
  • Minium 10 years of experience in GMP regulated pharmaceutical industry.
• Knowledge, Skills and Abilities
  • Good technical knowledge,possess problem solving and logical thinking capabilities.
  • Should have competent verbal & written communication skills.
  • Proper management skill and leading ability.
  • Good leadership quality and communication skill.