The Associate II, Compliance is responsible for conducting activities to ensure site compliance to cGMP regulations as well as internal quality procedures. The Associate II Compliance is responsible for managing and conducting Investigations, Product Quality Complaints, CAPAs, Deviations and Change Controls. Ensures adherence to SOPs and policies. Provide assistance during regulatory, corporate and internal audits.
Area of Responsibility:
Conducts Investigations of Site Incidents/Deviations and Product Quality Complaints in Trackwise system and provides final review.
Ensures a robust deviation management program is executed to ensure effective root cause analysis and corrective and preventative action identified and completed
Reviews and approves Change controls, CAPA and Global CAPA and monitors the effectiveness of CAPA.
Handles Quality Metrics Management - responsible for the collection and reporting of Quality Metrics. Trending of Site Incidents, Product Quality Complaints, Change Controls, Out of Specifications, Out of Trends and CAPA on monthly, quarterly and annually basis
Assists in ensuring FDA Readiness Plan for the facility. Provides support for all regulatory audits, internal/external inspections, and other audits. Responsible for follow ups on all related Operational findings from FDA, other regulatory bodies, internal audits, etc.
Participates and conducts mock inspections to prepare the facility for audits and assesses gaps in the system; review documents for compliance to current regulations and cGMPs.
Identifies compliance issues and supports the implementation changes for constant improvements.
Supports adherence to SOPs and policies and assists in ensuring that procedures reflect current practice. Create new SOP's and revise the existing SOP's as applicable.
Reviews and approves Qualification Protocols and Reports for equipment and product validations/verifications.
Requirements:
Minimum of Bachelor's degree.
Minimum five (5) years of experience within the pharmaceutical industry in quality function role.
Experience working in an international multicultural matrix organization.
Demonstrated ability and knowledge of QMS and driving investigations to completion.
Thorough understanding of GMPs.
Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise or similar QMS, LMS (Learning Management System) etc.
Strong knowledge of project management principles, practices, techniques and tools.
Excellent interpersonal and communication, both written and verbal, skills.
Excellent organizational and time management skills; must be able to prioritize and manage multiple assignments simultaneously while working independently or with others as needed.
A self-starter with a hands-on approach and a can-do attitude.
The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).