Lead/Director, Quality Control

Company: Dr Reddy Laboratories LA LLC
Location: Shreveport
Posted on: October 12, 2019

Job Description:

DESCRIPTION

Position at Dr. Reddy's Laboratories, Inc.

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.

Lead/Director, Quality Control

This position will be based in Shreveport, LA. Relocation assistance provided to out-of-area candidates.

Manages daily operations in the quality control laboratory. The laboratory performs chemical, microbiological, and physical tests on raw materials, packaging components, in process materials, and drug products. Drug products consist of solid dose drug products and semi-solids. The qualified individual will be responsible for leading a culture of safety and quality and assuring compliance with all regulations. The position will also be responsible for leading activities associated with new product development such as method verification, validation, and transfer activities.



Responsibilities:

* Manages overall QC laboratory.

* Assures employee access to safety training, technical data, and PPE; and providing well defined and safe laboratory procedures, well maintained equipment and continuous monitoring.

* Ensures compliance with all applicable laws, regulatory agency requirements (e.g., FDA, OSHA, USP), corporate policies, standards, and site procedures.

* Organizes timely, accurate and reliable testing of various types of samples such as raw materials, intermediates, and drug products (release/validation/stability)

* Ensures test methods are validated, equipment is calibrated and well maintained, and laboratory data are accurate and retained according to regulatory requirements.

* Manages environmental and water quality monitoring and testing.

* Supports site goals and projects utilizing technical expertise and special studies.

* Assesses staff performance

* Provides leadership and communication on all quality control matters with both internal and external customers.

* Utilizes appropriate statistical and analytical tools to investigate any questionable results

* Develops and implements appropriate corrective and preventive actions for continuous improvement.

* Maintains the laboratory in an inspection readiness state

* Provides technical support to manufacturing.

* Makes decisions on acceptability of all test results generated in the laboratory.

* Develops and implements comprehensive training program for laboratory.

* Plans and executes method development and validation studies, laboratory instrumentation upgrades and comprehensive test failure investigations.

* Regular interaction with laboratory analysts, supervisors, peers, and QC management.

* Provides analytical chemistry and microbiology support required for in-process controls and process validation.

Requirements:

* S. degree in Chemistry or related field. Master of Science degree preferred.

* 5 years of experience in a management role in a laboratory environment.

* 10 years of experience in the pharmaceutical industry in a technical capacity (laboratory operations, quality, etc.).

* Solid experience with method development and validation, stability requriements, and program management. Strong laboratory testing skills including mastery of chromatography (HPLC, GC) and other analytical instrumentation.

* Fully versed in cGMPs, FDA, OSHA, and ICH requirements, and other regulatory agency requirements with knowledge of inspection and process improvement tools.

* Excellent communication (verbal and written), negotiation, interpersonal, and leadership skills.

* Excellent problem-solving, decision making, prioritization, and trouble-shooting skills

* Knowledge of operating budgets and capital project management.

* Proficient with use of SAP, LIMS, CDS, MS Office and other computer programs, and statistical applications.

* Training program development and delivery to professional staff



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.

Keywords: Dr Reddy Laboratories LA LLC, Shreveport , Lead/Director, Quality Control, Executive , Shreveport, Louisiana