Analyst I Complaint Process Non-Fix-Term Fixed-Term Positions
Analyst I Complaint Process Non-Fix-Term Fixed-Term Positions
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Salary Not Disclosed
1 Vacancy
Job Description
- Assure complaint records meet global requirements.
- Product complaint documentation investigation and review of all nonmedical complaint content. Responsible for reviewing Medical complaints that involve a nonmedical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
- Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.
- Identification of potentially reportable events and notification to appropriate functional groups and management.
- Interface with Third Party Manufacturers health care professionals general public internal customers AbbVie functional areas and regulatory agencies.
Qualifications :
- Knowledge of global regulatory requirements for pharmaceutical medical devices and combination products.
- Knowledge of FDA requirements for Quality Systems pharmaceutical products and Medical Device Reporting regulations 21 CFR 803 820 and 211 is preferred.
- Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
- Solid written/verbal communication and organizational skills.
- Knowledge and application of computer systems: MS wordexcel
- Ability to work with crossfunctional teams and to interact effectively with peers management and customers.
- A Bachelor Degree required or 12 years of relevant work experience. (Preferred degree in technology or scientific background)
- 02 years work experience in a cGMP Good Manufacturing Practice) related industry or in a clinical setting (preferred).
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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No
Employment Type :
Fulltime
Employment Type
Full-time
