- 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.
- Education: MinimumMSc/B. Pharm or any equivalent degree
- Skills and Abilities Proficient in Analytical Method development, validations and transfer activitiesKnowledge on regulatory guidelines and compendial proceduresAbility to resolve the issues related to day to day analytical activitiesAbility to manage the work to meet the commitments despite challenges
- Experience Minimum 12 to 16years of experience in GMP regulated Pharmaceutical Industry
Manager- Quality Control, QC Compendia - Bengaluru, India - Apotex
Description
About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
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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
Job Requirements
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.