Associate - QA Operations & Validations
Company: Disability Solutions
Posted on: September 19, 2023
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.Associate - QA Operations & Validations - Shreveport,
LA.Purpose: To administer support in collaborating with Quality,
Manufacturing, Packaging, Technical Services, and Engineering teams
to provide quality oversight of new equipment, systems, and process
validation. This position will also assess changes to existing
equipment and processes in a pharmaceutical manufacturing DRL
Shreveport Plant. Job Requirements:
- Bachelor's degree in a Science, Engineering or a related field
with minimum of 6- 8 years' experience in pharmaceutical industry
in a technical capacity.
- Experience writing, reviewing, and/or approving validation
- Experience necessary with pharmaceutical process validation,
cleaning validation, equipment, utilities, and computer system
- Ability to make sound decisions and provide guidance related to
Quality matters on a variety of site projects.
- Demonstrated critical thinking skills with ability to define
and investigate problems.
- Strong analytical skills, written and verbal communication
- Thorough knowledge of cGMPs and other regulatory requirements
in the pharmaceutical industryPreferred Experience:
- Experience and knowledge with a variety of root cause analysis
- Demonstrated ability to work with counterparts to accomplish
- Must be able to manage multiple deliverables, possess excellent
organizational skills, be detailed oriented and possess good
- SAP experience preferred
- Vendor managementPrincipal Responsibilities:
- Reviews, approves, and provides approval as a quality team
member for validation and qualification protocols and reports of
pharmaceutical process and equipment to ensure:
- Compliance with cGMP and internal procedures.The protocols are
executed as intended and investigated to resolve any
deviations.Conclusions are accurate based on the results obtained.
- Review of GMP documents including but not limited to Change
Control documents, Master Batch Records, SOPs, APRs,
specifications, or Laboratory Data.
- Provide quality oversight of the facility and equipment
including their calibration through periodic reviews.
- Contributes or leads site initiatives and quality improvement
projects, as well as process, facility, utility, and equipment
- Knowledge of and experience with applicable Quality Management
- Assures that systems and processes, in the following areas, are
defined and executed in compliance with cGMP and applicable company
- Perform other tasks as assigned by Lead or Management 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: Disability Solutions, Shreveport , Associate - QA Operations & Validations, Other , Shreveport, Louisiana
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