Manager, Quality Systems Engineering Job in Saint Joseph 64501, Missouri Us
JOB DESCRIPTION:
Overview:
This position will be principally responsible for the quality review and approval of validation, engineering, laboratory, and computer system related documents to ensure that the documents are accurate,and complete,and meet internal and external requlatory requirements such as GMP, ISO, GAMP, ISPE, etc. This position is also principally responsible for establishment of any statistical sampling and control associated with the quality of products manufactured by TAH. This position will interface with FDA and other regulatory auditors during inspections. The individual will be familiar with or be an expert in all of the following areas related to quality engineering: Qualification of equipment, facilities and utilities, Validation of Processes and Computerized Systems inclusive of Part11, establishment of Statistical Sampling Methods, Solid and Liquid Manufacturing, and Aseptic Manufacturing.
Responsibilities:
- Monitors the validation and engineering programs supporting manufacturing and the quality system to ensure that they are compliant to camp and other internal and external regulatory requirements and that the site has a system for adequately evaluating these activities.
- Represents the Quality organization via signature approval associated with the implementation and validation of all site GxP computer systems and/or software applications to ensure compliance with cGMP and other internal and external regulatory requirements and that the site has a system for adequately evaluating these activities.
- Provides Statistical expertise to the Facility for the establishment of sampling plans and interpretation of data needed to define process capability.
- Monitors the external guidance's associated with validation (ISPE, ISO, and GAMP) to ensure that the site is compliant and maintains up to date systems and requirements.
- Provides and appropriately responds to Metrics associated with the state of compliance.
- Follows Teva Safety, Health, and Environmental policies and procedures.
Qualifications:
- BA/BS Degree in science field, e.g., Pharmaceutical Engineering, biology, Microbiology, Chemistry, Pharmacy.
Program Certification through ASQ, ISPE or other relevant industry organization. Statistics course work and / or certification through ASQ preferred, but not required.
- Minimum of 5+ years of pharmaceutical or related work experience with emphasis in Validation. Experienced in computer systems validation, manufacturing, validation, quality systems and cGMP auditing.
- Excellent knowledge of drug regulations (cGMPs).
- Experience in Statistics and the implementation of statistical sampling plans and statistical controls.
- Strong interpersonal and written and verbal communication skills. Must be able to interface positively with Regulatory Agencies, Vendors and Company departments.
- Strong Management skills
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