Senior Quality Engineer GMP
Senior Quality Engineer GMP
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Purpose
The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations performance of product impact analysis and corrective and preventive action for events leading and participating in investigations approval of standard operating procedures oversight of the plant calibration program quality improvement programs and assurance of cGMP and compliance for the manufacturing plant.
Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others authoring and of newly identified qualification/validation protocols review and approval of critical planned maintenance routines and other quality assurance tasks assigned.
Responsibilities
- Responsible for implementing and maintaining the effectiveness of the Quality System.
- Support the ensure that all quality goals are met and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
- Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
- Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
- Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
- Approves standard operating procedures; ensures procedures comply with policy and make sense.
- Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
- Auditing of commissioning and validation documentation.
- Develops product quality plans documents and systems by creating product specifications quality specifications quality plans risk analyses and FMEAs. Develops and implements statistical quality programs and process monitoring systems.
- For specific U.S. manufacturing sites performs batch release.
Qualifications :
- Bachelors degree preferably in Biology Chemistry or Engineering
- 6 years of overall experience in Manufacturing Quality or Engineering
- Good verbal and written communication skills.
- Good problem solving and analytical skills
- Good interpersonal relations / communications skills
- Knowledge of quality / compliance management as well as regulations and standards affecting API Bulk Drug or Finished goods manufacturing.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our shortterm incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
