Lead/Director, Quality Control
Company: Dr Reddy Laboratories LA LLC
Posted on: October 12, 2019
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.
* 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
* 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
* 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
* Develops and implements comprehensive training program for
* Plans and executes method development and validation studies,
laboratory instrumentation upgrades and comprehensive test failure
* Regular interaction with laboratory analysts, supervisors, peers,
and QC management.
* Provides analytical chemistry and microbiology support required
for in-process controls and process validation.
* S. degree in Chemistry or related field. Master of Science degree
* 5 years of experience in a management role in a laboratory
* 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
* Knowledge of operating budgets and capital project
* Proficient with use of SAP, LIMS, CDS, MS Office and other
computer programs, and statistical applications.
* Training program development and delivery to professional
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
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