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Manager, Quality Assurance

Chattanooga, Tennessee

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  • Full Time
  • Level: Entry
  • Glassdoor Reviews and Company Rating

Overview

You’re the one who will help us meet and exceed the quality standards that medical professionals and patients expect from us. Collaborating with like-minded, inventive colleagues, you’ll take a balanced approach, tackling challenges, learning from mistakes, and creating solutions that empower our fast-growing company. Join a workplace that’s big on open communication and fueling your career growth. When can you start?

Success Profile

What makes a great Manager, Quality Assurance at Sun Pharma? Take a look and see how you match up.

  • Collaborative
  • Communicator
  • Detail-oriented
  • Independent
  • Problem-solver
  • Team player

Our Culture

Discover an environment that’s open and transparent. Every day is a new opportunity to learn and grow, surrounded by powerful reminders of the impact your role has on patients’ lives. This is the Sun Pharma way of life. And we can’t wait for you to be a part of it.

Benefits

We’re in your corner – in so many different ways. Sun Pharma wants you to have the benefits, support, and rewards of a job well done.

  • Career Growth

    Get support for your career growth and development.

  • Benefits Programs

    Discover comprehensive benefits to support the health and wellness of you and your family.

  • Time Off

    Enjoy paid time off and leave-of-absence options.

  • Compensation

    Earn competitive compensation with incentive programs that reward our shared success.

  • Working Conditions

    Work confidently in the safe, clean, and regulated work environment that we foster.

  • Team Environment

    Collaborate in a workplace that’s rooted in our values and encourages cross-team engagement.

Manager, Quality Assurance

Chattanooga, Tennessee
Category Quality Job ID R-44814
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Job Description

- Management and oversite of Quality Assurance roles and responsibilities; including yearly goal setting, mid-year and end-of-year reviews, and other managerial      requirements needed for direct reports.
- Job specific training for all Quality Assurance personal engaged in release of active pharmaceutical ingredients. 
- Implementation of the cGMP training program for all Chattem Chemical personnel.
- Participates in FDA inspection Preparation. 
- Interface with purchasing departments on any quality related issues with Intermediates, Raw Materials or APIs.
- Ensure overall compliance of Quality Assurance/Quality Control activities and plant operations related to manufacturing, testing, and release of all components, bulk finished products, and packaged API’s.
-  Assist in the development and management of Quality department operating and capital budgets in support of ongoing operations and new initiatives; assurance that capital budget initiatives are executed to support department objectives. 
- Provide leadership, training, and development opportunities to Quality Assurance roles in order to enhance team skills and performance. 
- Maintain awareness of compliance initiatives relevant to areas managed.
- Develop Standard Operating Procedure applicable to areas managed, understand and interpret Standard Operating Procedures governing all aspects of plant operations including area not under direct control. Maintain awareness of new cGMP initiatives affecting Quality operation under the purview of Site Head – Quality. 
- Serves as a member of the site audit team and conducts internal inspections of Chattem Chemicals. 
- Reviews and approves investigations. Conducts investigations into drug substance components or drug substance failures as needed or directed by the Site Head – Quality.
- Reviews and approves operational quality documentation such as environmental monitoring, cleaning, calibration, equipment operation and maintenance related to the internal manufacturing and analytical laboratories. 
- Ensure quality systems are monitored and established metrics are met. 
- Provide support during regulatory agency site inspections.
- Assists in dispositioning of rejected materials.
- Serves as back-up to the Site Head – Quality in their absence.
- Provide support during routine customer site audits. 
- Maintain site certifications such as Halal, Kosher, HACCP, Etc.
- Manage and ensure the validation program is functioning as intended.
- Serves as back-up to the Manager of QA Compliance in their absence. 
- Manage and ensure the APQR program is functioning as intended.
- All other activity instructed from time to time.

Requirements

- Advanced degree in Chemistry or related field with at least 5 years in quality assurance/ quality control.

- No less than 5 years Quality Control/QA experience in a cGMP/API environment.

- Previous management experience. 

- Exceptional user of Microsoft Office Suite, to include Word, Excel, Access and Power Point. 

- Proven history of Compliance improvements. 

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