Assoc Process Control/compl Mgr

**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

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