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Senior Quality Control Manager
2 months ago
We are seeking a highly experienced Senior Quality Control Manager to join our team at Sun Pharma. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality and regulatory compliance in our pharmaceutical products.
Key Responsibilities- Monitor and maintain regulatory compliance with pharmacopoeia monographs, general chapters, and FDA guidelines related to quality control.
- Provide technical expertise and support to our chemists in the QC laboratory, ensuring timely completion of activities and continuous improvement of individual output.
- Support laboratory management in performing investigations, laboratory incidents, and CAPA-related activities to meet cGMP compliance requirements.
- Execute analytical method transfer activities for new projects and prepare/review technical documents, including technical reports, gap assessments, and change controls.
- Provide technical expertise and support to laboratory staff, serving as a subject matter expert with no direct reports.
- Minimum BS in Chemistry or equivalent degree in a related discipline; MS preferred.
- Strong and effective people management and interpersonal skills.
- Ability to organize complex work assignments and oversee analysts and staff to complete tasks and projects on time.
- Strong functional knowledge of cGMP compliance and excellent working knowledge of USP, EP, ICH, and FDA guidelines.
- Strong planning, written, and oral communication skills, as well as excellent problem-solving skills.
- A self-starter with a hands-on approach and a can-do attitude.
- Environmental conditions related to manufacturing/production/warehouse environments.
- Physical demands include standing, walking, sitting, stooping, kneeling, crouching, crawling, pushing, and bending.
- Ability to move pallets/equipment weighing up to approximately pounds using suitable moving equipment.
- Ability to stand, ambulate, and reach as required by job duties while navigating the office, lab, warehouse, and/or plant floor working environments.
- Minimum BS in Chemistry or equivalent degree in a related discipline; MS preferred.
- Strong and effective people management and interpersonal skills.
- Ability to organize complex work assignments and oversee analysts and staff to complete tasks and projects on time.
- Strong functional knowledge of cGMP compliance and excellent working knowledge of USP, EP, ICH, and FDA guidelines.
- Strong planning, written, and oral communication skills, as well as excellent problem-solving skills.
- A self-starter with a hands-on approach and a can-do attitude.
As a Senior Quality Control Manager at Sun Pharma, you will be eligible for our comprehensive benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, and employee assistance program. You will also receive various paid time off benefits, including vacation time and sick time.
