Title: | CAPA Consultant |
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ID: | 1009 |
Location: | Houston |
Department: | Client Services |
Job Related Skills: | 21 CFR 803, 21 CFR Part 11, 510K, Auditing, CAPA, Data Analysis, Data Integrity, Design Control, Design History File - DHF, Design of Experiment - DOE, EP Compendial Test Methods, EU Annex 11, FDA Audit Experience, FDA Audit Remediation, FDA Regulations, FMEA / PFMEA, Human Factors Engineering |
Synergy Bioscience strives to maintain and inspire professional excellence by providing consulting services to the Pharmaceutical and Medical Devices Industries. Synergy Bioscience offers competitive compensation plus a stimulating and collaborative work environment. As a consulting company, we are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm, and diligence.
What we are looking for
This is an immediate and exceptional opportunity to join our dynamic team of CAPA remediation experts within their field. Synergy Bioscience is immediately seeking a Senior-Level CAPA Guru to provide CAPA process support to one of our clients in the medical devices industry. This is a highly visible role within our client organization. One in which a great deal of success will be determined by your ability to lead and execute a remediation project for one of the most prestigious medical devices clients in the world.
In your Position, You Will be in a highly influential role and have a once-in-lifetime opportunity to make an immediate impact on one of the top global medical device companies in the world.
To be considered for the position, you must:
- Have solid experience in the CAPA process and root cause analysis methodology and tools.
- Identify and implement transformative directives to resolve outstanding or newly identified CAPA deficiencies.
- Interact with, advise, and influence personnel working in CAPA Process & Quality System Remediation.
- Track progress of workers and resources implementing CAPA Remediation.
- Regularly report to various levels of management on the progress of Quality System Remediation.
- Work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Strictly adhere to safety requirements.
- Have effective oral, written, and presentation communication skills.
- Have the ability to work in collaborative and independent work situations and environments with minimal supervision.
- Have the ability to remain calm and receptive in fast-paced situations.
- Have excellent analytical and problem-solving skills.
Required academic background:
- Bachelors Degree in Engineering or related technical field; or experience of such kind and amount as to provide a comparable background.
- Minimum 10 years experience in CAPA, Quality System Management, Quality System auditing, or Quality System remediation.
- Experience recording and analyzing data and clearly expressing conclusions and recommendations in writing. Experience managing multi-functional teams
More Information about the job:
6+ months, with a possibility for extension.
Start Date: Monday, Nov 27, 2017.
Excellent hourly rate + expenses
Job Type: Contract
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