Assistant Manager, Quality Control

Job Summary

Responsible and accountable for Analytical Method Transfer /Verification related to Site Technology Transfer, SDC/Compendia and Cleaning methods; Training & Documentation, Change Control management, Sample management and SOP updates.

Monitoring and ensuring the readiness of QC laboratory for audits at all time for the respective sections.

Job Responsibilities

• Assessment/Review of scheduled projects with respect to Analytical method transfer/ verification, SDC and Compendia activities
• Execution of method transfer/ verification activities related to STT, SDC and Compendia with proactive discussions and planning
• To ensure initiation and completion of Analytical Method Transfer/verification studies within the stipulated time lines
• Review and approval of Analytical Method Transfer/verification protocols, reports or any related documents
• Monitoring of Lab investigations and providing guidance in the execution and closure of the same
• To ensure alignment and engagement of manpower and equipment in a sustainable manner
• To develop Analytical competency in the team through Qualification and Training for the required techniques
• To ensure availability of all materials/requirements for the execution with pre-planning
• Coordination/meetings with the cross functional teams within ARPL and GTA as and when required.
• Awareness/ training on safety procedures to the team to ensure no major safety issue occurrence
• Handling of LIR/Deviations if any related to method transfer/ verification activities
• Ensuring the compliance to the adhered procedures in the functional area.
• Any other additional responsibilities assigned by Department head, as and when required.
• 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 duties as assigned.

Job Requirements

• Education:
  • MinimumMSc/B. Pharm or any equivalent degree
• Skills and Abilities
  • Proficient in Analytical Method development, validations and transfer activities
  • Knowledge on regulatory guidelines and compendial procedures
  • Ability to resolve the issues related to day to day analytical activities
  • Ability to manage the work to meet the commitments despite challenges
• Experience
  • Minimum 7 to 14years of experience in GMP regulated Pharmaceutical Industry