Quality - Operations Process Compliance Specialist
Validation & Engineering Group, Inc
Humacao, Puerto Rico
hace 2 días

Company Description

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, manufacturing operations among other services.

Job Description

This position is accountable for timely investigational processes within Humacao Site OSD manufacturing operations and; for the corresponding timely implementation and effectiveness of Corrective and Preventive Actions (CAPA) plan.

Also accountable for ensuring investigations are performed within the standard scrutiny of governing compliance bodies. Promote and model the BMS Core Behaviors and facilitates teamwork.

The incumbent of the position must comply with all Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

1. Executes and ensures that all Quality Events (QEs) and CAPAs are completed / closed within the established timeframe, utilizing the right tools to measure effectiveness to prevent reoccurrence.

2. Monitors and assures that action plans have been implemented to eliminate reoccurrence.3. Reviews and provides input to regulatory submissions applicable to area of responsibility.

4. Interacts with regulatory compliance agencies with respect to Quality Events. 5. Provides written responses to regulatory observations as well as ensuring implementation of commitments.

6. Leads QE’s and CAPA’s trend evaluation.7. Conducts systematic QEs evaluations to minimize risk of reoccurrence and; ensures the effectiveness of CAPA’s.

8. Supports establishment of process monitoring parameters and control limits.9. Manages Quality Council metrics (i.e. QE’s and CAPA’s) and shares trends and gaps with management.

10. Evaluates and revises manufacturing documentation resulting from a compliance gap and; may assist in providing training related to the revised manufacturing documentation.

11. Creates awareness of trends and addresses situations with the affected area.12. Represents the manufacturing department in Quality Fact Findings Meetings.

13. Participates and represents the manufacturing department in all process compliance initiatives.14. Performs as the key contact during regulatory inspections.

15. Supports all site Initiatives and any other assignments based on business needs.16. Revises and updates SOPs to ensure robustness in our operations to reduce / eliminate potential investigations.

Qualifications

  • BS Degree in Science, Pharmacy or Engineering
  • Five (5) years of experience in an Oral Solid Dosage Manufacturing facility.
  • Strong technical writing and presentation skills
  • Experience in root cause analysis methodologies
  • Ability to interpret and analyze statistical data
  • Operational and scientific investigation expertise
  • Knowledge in cGMP’s, OSHA, EPA and other regulatory standards
  • Knowledge of computers applications (Microsoft Word, Excel, Power Point)
  • Excellent interpersonal skills and team work oriented
  • Excellent communications skills in Spanish / English
  • Additional Information

    Positions available for Puerto Rico.

    Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.

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