1. Performs shop floor walk through audits and challenge adherence with area procedures, coaching and quality support in alignment to the business unit to optimize compliance and efficacy.
2. Manage quality systems such as Product Complaints, Training, NOE, CAPA, Change Control, Retention Samples and Document Retention.
3. Assess, review, approve, monitor and manage CAPA records ensuring corrective and preventive actions are robust, timely and effective and do not adversely affect product quality.
4. Assess, review, approve, monitor and manage NOE records ensuring investigations are robust, timely and do not adversely affect product quality.
5. Administration of the Training System to assure compliance.
6. Assess, review, monitor and manage Change Control records ensuring corrective and preventive actions are robust, timely and do not adversely affect product quality.
7. Participate in Quality Systems meetings, as required.
8. Administration of the Retention and Document Retention, to assure compliance.
9. Prepare presentations to train new personnel on cGMP and site relevant processes and all personnel and contractors on cGMP revised SOP.
10. Review, evaluation and approval of SOP, Forms, Change Controls and Validation Documents according to established procedures to ensure compliance, efficiency and clarity.
11. Ensures compliance of all procedures (SOP’s) to avoid potential regulatory and compliance issues.
12. Timely report of potential significant events to Quality and Site Management.
13. Follows all safety guidelines established by the Company, including proper use of safety equipment and relevant safety procedures.
14. Support the assessment, review, and approval of deviations in accordance with FDA & ICH standards and cGMP requirements ensuring timely completion and supported conclusions from the Quality Control/Assurance, Manufacturing/Packaging, Engineering, PR&D and Material departments. Provides scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified in order to perform a systematic approach. Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities.
15. Provides support to the area QA Manager during the budget preparation activities.
16. Carry out other duties as assigned that are deemed reasonable and within the broad scope of the position.
1. Knowledge in analytical data evaluation and audit a plus. Literate in computer systems such as Excel, Word and Power Point.
2. Incumbent must be fully bilingual in both English and Spanish, with a strong, thorough, and concise written and verbal communications skills and above average computer literacy (MS-Office).
3. Excellent technical writing skills are required.
4. Incumbent must posses’ strong mathematical skills to facilitate the interpretation of the programs evaluated.
The incumbent must be able to work in a team-based matrix environment.