Senior Manager, Qual Assur-ARPL-AQAQ AR

Job Summary

Responsible for effective review and approval of Laboratory investigation reports / Deviations / Corrective and preventive actions (CAPA’s)/ change controls/ method transfer/ validation protocols and reports in a timely and compliant manner.

Job Responsibilities

• Review and approval of lab investigation reports , Deviations, Corrective action and preventive actions (CAPA’s) and Temporary change controls.
• Provide guidance on technical assessment/ investigations to team members and stake holders to ensure compliance.
• Review of standard operating procedures.
• Assessment and approval of change controls.
• Review and approval of instrument qualification and calibtration documents in timely manner.
• Review and approval of method transfer and validation protocols/ reports.
• Review and approval of specifications and MOA.
• Provide support to self inspections and audits by regulatory authorities / third parties as required.
• Responsible and accountable for managing subordinates and to provide all required training requirements, tools and follow procedures in accordance with applicable regulatory and other pertinent requirements.
• Provide training as required.
• Recruit, train, develop and manage effectively the ongoing performance of the direct reports, which includes but not limited to:
  • Reviewing and updating team developing plans, ensuring that all the team members are properly trained and qualified to execute their duties.
  • Providing coaching, feedback and recognition.
• Perform all work in support of our corporate values of collaboration,courage, perseverance and passion. Demonstrates strong and visible support of values.
• Communicate corporate vision and goals to direct reports in an effective and efficient manner.
• All other duties as assigned.

Job Requirements

• Education
  • Minimum Bachelor of Pharmacy / Science or any equivalent degree.
• Knowledge, Skills and Abilities
  • Possess sound knowledge in quality management system which comprises of change controls, deviations and LIR’s
  • Hands on experience in Trackwise application, LIMS and Empower application.
  • Maintains good interpersonal skills and communication skills.
  • Knowledge on method transfer and validation activities.
• Experience
  • Minimum 8-12 years of experience in GMP regulated pharmaceutical industry.