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Site Quality Head

Company: Disability Solutions
Location: Middleburgh
Posted on: February 12, 2024

Job Description:

At Dr. Reddy's "Good Health Can't Wait" By joining Dr. Reddy's, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.Diversity, Equity & InclusionAt Dr. Reddy's, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. Purpose: Our Middleburgh, Site Quality Head will be in charge of Quality Assurance, Quality Control and Quality Compliance, ensuring compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulations. The incumbent will be responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The incumbent will have an excellent understanding of cGMP requirements. The position requires a driven leader who works independently and collaboratively, an experienced in cGMP requirements, quality control, attention to detail, and will manage excellent partnership and communication with other functional areas and sites. Responsibilities: --- Overall responsibility for quality operations and initiatives, including:

  • Quality Assurance, Quality Control, and Quality Compliance management.
  • In collaboration with the Quality Assurance team, responsible for:
    • Documentation control (master batch record, specification & method)
    • Batch record review and product disposition
    • Investigations, complaints, deviations, CAPAs, APRs
    • Production and Pharmaceutical Development support
    • Annual Product Reviews, GMP training and SOP review
    • Validation /qualification documentation review & approval
    • QA Operations - inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site
    • Develop, maintain, and enhance training programs and systems at Middleburgh site
        • Quality Compliance management:
          • In collaboration with the Quality and Compliance team from North America Region, supports for
            • All audits, internal, external - regulatory, client and vendor
            • Vendor management program
            • QA Agreements with clients & contractors
            • License renewals
            • Quality Control Management
              • Approve or reject starting materials, packaging materials, labeling and intermediate, bulk and finished products in relation to their specifications
              • Evaluate completed formulation records and other relevant information to ensure procedures were followed, product tests performed appropriately and acceptance criteria met
              • Review sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures for intended use
              • Approve and monitor analyses carried out under contract through private labs
              • Lead the activities associated with monitoring the maintenance of the department(s), premises, processes, and equipment
              • Ensure that the appropriate validations, including those of analytical procedures, and calibration of control equipment are carried out
                  • Budget
                    • Plan and monitor the Quality Assurance department's annual budget and develop any action plans necessary to ensure achievement.
                    • Leadership
                      • Manage, develop and motivate the Quality Team:
                      • Make decisions pertaining to the workforce according to the company's current policies and guidelines.
                      • Implement an efficient organizational structure.
                      • Support continuous improvement and/or cost reduction projects
                      • Determine the professional development needs among the managers and the quality group and elaborate action plans in collaboration with the Human Resources Department.
                      • Develop and Maintain Key Performance Indicators for the Quality Operation and discuss performance/opportunities.
                      • Coach employee & share expertise in quality aspect, decision making and problem solving.
                      • Ensure a strong relationship with DRL's customers.
                      • Develop a client biased attitude in the Quality organization. Qualifications / Skills: Bachelor of Science (B. S.), Masters preferred, and from the pharmaceutical industry
                        • 15 years of experience in a pharmaceutical environment, in Quality Operations, with FDA Audit experience
                        • Extensive knowledge of US current Good Manufacturing Practices
                        • Expertise in Quality Control Laboratory Operations
                        • Microbiological services experience either through direct or line management
                        • Excellent knowledge of validation requirements
                        • Knowledge and experience with the Pharmacy code of Regulations, Board of Pharmacies, and US FDA cGMPs The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location. Salary range (Annual): $135K - $185K Relocation assistance will be provided if required Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.Equal Opportunity Employer: An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, col or, religion, sex, age , sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Keywords: Disability Solutions, Albany , Site Quality Head, Accounting, Auditing , Middleburgh, New York

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