Associate Director, Quality Assurance

Dr. Reddy’s Laboratories, Inc. Shreveport, LA 5/2/2012

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Job Description

At Dr. Reddy’s, a global pharmaceutical company, 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.

Please Note: Unless an order has been placed with your agency for this role, we will not accept any calls or other inquiries from recruiters for this position. If a candidate is submitted despite this, we are not bound by any agreement terms and can hire the person as we see fit.

Job Title: Associate Director, Quality Assurance

Job Location: Shreveport, Louisiana

Direct all Quality Assurance and Quality Control functions for Dr. Reddy’s Laboratories Louisiana, LLC., Shreveport facility
Serve as site leader for regulatory compliance inspection and any communication with governmental regulatory authorities
Ensure that appropriate Quality Management Systems (QMS) are in place and in use and effectively monitored to facilitate compliance with GMPs and to enhance Quality Management and Culture within the Shreveport site
Establish and manage Quality policies and procedures for receipt, manufacturing, packaging, testing, documention, storage, and transporting applicable Dr. Reddy’s products
Responsible for assuring organized audits and training programs to promote and assess compliance
Responsible for assuring QC Laboratories are well organized, in compliance with all legal requirements, and suitable for purpose, including safety of laboratory operations
Ensures that sound science and validated methods are in use and all work is documented as per requirements, including but not limited to drug and packaging components, intermediates and finished products, and stability monitoring to support shelf life
Develop and maintain validation of systems, methods, processes and equipment ensuring compliance with applicable GMP
Ensure appropriate assessment of deficiencies and risks and root cause analysis, followed by preventative and corrective actions to prevent reoccurrence
Prepare a strategic Quality plan and annual objectives, in line with the Global Quality Strategy; monitor performance via appropriate metrics and act to ensure that objectives are met
Assist with corporate supplier and service provider audits as needed
Investigate, reply to, and assure corrective action on customer complaints about product quality in accordance with cGMP which emphasizes continuous improvement

Job Requirements

B.S. or M.S. in Scientific Discipline i.e. (chemistry, biology, pharmaceutics, or life science)
Strong understanding of pharmaceutical manufacturing, packaging and testing processes, and management of Quality Management Systems
Thorough understanding and familiarity with GMP regulations, including 21 CFR 210 and 211, ICH guidelines, FDA guidance documents
Excellent verbal and written communication skills, organizational and time management skills; strong attention to detail

From unsurpassed career momentum to our innovative perks and benefits, we do everything we can to make sure our employees not only do exceptional work, but have exceptional rewards, as well. If you are committed to making a profound impact worldwide, we invite you to learn more about our career opportunities, our products, and our plans for the future. Please visit us at www.drreddysusjobs.com.

**We are a corporate office and not a doctor’s office. Unsolicited resumes sent to our office will not be considered for any open positions. Only interested parties that apply through our Career website will be considered for positions within Dr. Reddy's Laboratories, Inc.**

As an Equal Employment Opportunity/Affirmative Action employer, Dr. Reddy’s Laboratories, Inc. and its subsidiaries, does not discriminate in employment against applicants or employees on the basis of race, color, religion, sex (except where sex is a bonafide occupational qualification), national origin, age, mental or physical disability, status as a disabled veteran, armed forces service medal veteran, other protected veteran, or recently separated veteran, or any other basis prohibited by federal, state or local law.

Job Snapshot

Employment Type Full-Time

Job Type Admin - Clerical

Education 4 Year Degree

Experience At least 10 year(s)

Manages Others No

Relocation No

Required Travel Not Specified

Job ID 3011281CBP

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