At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddys, 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.
Site Quality Head - Shreveport, LA
Relocation Assistance will be provided if necessary.
Reporting to the Head of Quality & Regulatory the Site Quality Head is in charge of Quality Assurance, Quality Control and Quality Compliance, ensuring compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation
The position is responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality control, attention to detail, and excellent communication with other functional areas and sites.
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
APRs, 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 DRL Shreveport site
Quality Compliance management: In collaboration with the Quality and Compliance team from North America Region All audits, internal, external regulatory, client and vendor
Vendor management program
QA Agreements with clients & contractors
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 departments 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 companys 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 DRLs customers
Develop a client biased attitude in the Quality organization
Other duties as assigned
Bachelor of Science (B. S.), Masters preferred , related to the pharmaceutical industry
15 years of experience in a pharmaceutical environment, in Quality Operations , with FDA Audit experience
Extensive knowledge of US and EU current Good Manufacturing Practices
Expertise in Quality Control Laboratory Operations
Microbiological services experience either through direct or line management
Experience with a CMO would be preferable
Excellent knowledge of validation requirements
Knowledge and experience with the Pharmacy code of Regulations, Board of Pharmacies, and US FDA cGMPs
Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
Equal Opportunity Employer: Minorities/Women/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.