Engineering Compliance Specialist

Viatris•Vega Baja, PR

11d

About The Position

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. The Engineering Compliance Specialist ensures Engineering operations comply with regulatory standards, procedures, and policies. This role directly supports the Operations Maintenance area with Quality and EHS Compliance aspects. This includes SOPs revisions, CAPAs, QARs, CRs, Compliance to PQS, audits, etc. Acts as the Engineering main contact for all regulatory and internal audits and inspections. Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.

Requirements

Minimum of B.S. in Engineering (Chemical, Civil, Electrical, Industrial or Mechanical).
Minimum of eigh(8) years of experience in the field of compliance and/or applicable experience in Engineering functions supporting the pharmaceutical industry.
Root cause analysis and Trackwise Investigation process.
Laws, legal codes, procedures, and other relevant regulatory standards.
GMP, OSHA, FDA, and other relevant regulatory standards applicable to the pharmaceutical insustry.
Strong analytical and critical thinking skills.

Nice To Haves

Six Sigma DMAIC Certification is highly desirable.
Technical writing certification.

Responsibilities

Work closely with Engineering maintenance unit for the timely achievement of departmental regulatory (QA, EHS, DEA, etc.) commitments (QAR’s, CAPA’s, CR’s, investigations), providing support to the operational areas in their development, execution and tracking on time closure.
Define training structure according to corporate requirements, lead training initiatives, confirm and track compliance with regulatory training requirements of maintenance colleagues and sub-contractors as per the assigned training curriculum (Plateau and My University).
Generate and document Calibration alerts.
Support, as required, the Calibration and Maintenance programs compliance in areas such as work order documentation practices, due date reports, alarms, deviations and generate regulatory compliance metrics.
Contribute and assist in the development, revision, evaluation and implementation of the departmental SOP’s assurance policies, procedures, standards and manuals.
Provide representation, technical expertise, and guidance in resolving deviations or regulatory issues.
Develop and implement quality improvement/corrective action plans.
Lead root cause investigations and corrective action documentation and implementation.
Provides support for the internal and external audits for our regulatory systems.
Lead, as main contact, audit process and Engineering information and documents flow.
Generates and completes quality deviation investigations as necessary including QARS, implementing CAPAs, PM deviations, and CR.
Support and provide guidance on compliance engineering systems to sub-contractors providing support to EMU operations.
Define and implement Engineering Systems routine audit program.