USA - Principal Engineer
USA - Principal Engineer
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1 Vacancy
Job Description
Candidates cannot be allergic to Penicillin or Cephalosporins.
Description
JOB SUMMARY: Schedules plans and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System. Conducts internal audits and compliance gap analysis using the applicable quality manuals global and/or local procedures applicable country regulations directives standards inspection guidelines and compendia as requirements. Supports management during external inspections and participates in the preparation coordination and management of external inspections as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Other duties may be assigned:
-Evaluate quality data and determine strategies actions and initiatives to drive improvements in the facility. Work with cross functional teams on implementation.
- Support critical investigations using statistical techniques.
Qualifications:
Knowledge of cGMP and global regulatory guidelines such as EMA FDA and other health agencies.
Knowledge of Six Sigma methodology and LEAN principles.
Effective communicator at all levels; excellent written oral and interpersonal communication and presentation skills
Experience with pharmaceutical and/or device quality and compliance management systems desired.
Hands-on experience in drug product aseptic manufacturing operations is desired but not required.
Education and Experience
At least 5 years of directly related experience within the pharmaceutical industry or medical device experience. Experience with beta lactam manufacturing (Penicillin / Cephalosporins) is desired.
Bachelors degree required.
Previous experience with due diligence auditing compliance management or regulatory experience is a plus.
Additional Details
- Client Bill Rate : 84.00
- Does the position allow for the worker to be virtual/remote : Yes
- Shore Options Available for this Position : Onshore Only
- Direct or Indirect : Indirect
- Kronos Worker : No
- Shift : USA-1
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Full-time
Key Skills
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