• United States Of America, Usa

Job Description:

Associate Director of Quality Assurance - ( 190001CZ )



The Associate Director of Quality Assurance ensures compliance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products This position will help to further develop PPSs overall cGMP compliance and to support the day-to-day performance of cGMP compliance throughout the company This position will report directly to the Director of Quality


Provides leadership within the department and in projects and systems that interface with other departments May stand-in for Director of Quality as designated
Coordinates daily and monthly staffing schedules, capacity planning and cross-training efforts
Assists senior QA management with identifying staffing needs and contributes to hiring decisions
Ability to manage projects and systems
Conduct GMP investigations, including
Root cause analysis
Risk assessment
Impact evaluation
Technical report writing

Troubleshoot systemic issues and develop solutions
Review and approve controlled documents requiring QA approval signature, including
Client Audit Observations
Internal Audit Reports/Responses
Executed cGMP Batch Records
Master Batch Production Records
Process Simulation/Process Validation Protocols
Standard Operating Procedures
Material Specifications
Stability Protocols
Qualification Protocols

Review and approve activities conducted by outside vendors that directly impact the quality of products manufactured at PPS, including
Equipment qualifications

Ensure that deviations occurring during manufacturing are investigated and closed in a timely manner
Performs line clearances to ensure rooms have been adequately prepared for production runs
Other duties as assigned


Ability to work in a high demand office and manufacturing setting with extended time with on the floor activities (in the lab, manufacturing core, and warehouse settings)
Position may require extended hours including evenings and weekends
Ability to work in a safe manner with materials of potential high potency and/or toxicity in a limited capacity
Ability to cross-train in identified quality unit activities outside of the QA department in a supporting capacity



BA or BS in scientific field and/or equivalent

Minimum of ten (10) years progressive experience in a regulated cGMP industry is required, with five (5) years management experience

Experience in a GMP parenteral manufacturing environment

Strong knowledge of GMP regulations, guidance, and general compliance expectations

Experience with CMC regulatory filing requirements and activities a plus

Knowledge of current trends with regards to ICH and US regulatory inspections and expectations Also desirable EU regulatory knowledge

Regulatory inspection hosting experience mandatory, with experience for with global jurisdictions preferred

Experience with regulatory filing requirements

Must have experience using Microsoft Office suite (Word, Excel)

Primary Location United States-Kentucky-Lexington

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 19th Feb 2020

Key Skills:

Company Profile:

Piramal Enterprises Ltdarfix

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