Assoc Process Control/compl Mgr

2 meses atrás

Cidade Jardim, Brasil Labcorp Tempo inteiro

**Main activities**
- Oversee audit/inspection readiness and participate in audits from client and inspections from regulatory authorities.
- Liaise with QA and regulatory in development of CAPA actions for CQIs and audit/inspection findings
- Contribute and oversee implementation of CAPA actions as per the timelines
- Ensure PSS teams’ compliance to process with regular monitoring of the process, KPIs, CQIs etc. and design/implement necessary actions
- Represent PSS client audits and regulatory inspections, as needed
- Work closely with the operations and project management groups to ensure all PSS activities are performed according to the regulatory and contractual requirements
- Maintain a comprehensive understanding of PSS standard operating procedures (SOP), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Collaborate with training liaison and contribute to the development of departmental Job Aids, WIs, and review of SOPs, as appropriate.
- Ensure effective cross-functional global teamwork and maintain good team relationship across functional units.

**Requirements**:

- BS/BA in Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry
- Fluent English
- Previous experience with Pharmacovigilance / Drug Safety, CRO experience preferred.
- Previous experience supporting internal/ external audits, SOP/ Process development

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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