Job Description

Job Summary: Manager of Corporate Quality Compliance Responsible for review of.
Essential Job Functions:

• Responsible to monitor activities of Track wise as system owner.
• Responsible to monitor activities of Empower as system owner.
• Responsible to Identify newly published/revised regulatory guidelines of USFDA, EU, CA, TGA, MHRA and to prepare comparison report consists of Regulatory guideline requirements and current GSOP/GQS procedure (If available).
• Support to sites for conduct of regulatory inspections; which includes review of critical QMS documents/Investigations and tracking of open actions from various functions.
• Responsible to perform the gap analysis of global procedures (GQS/GSOPs and policies) against current guidelines and regulatory expectations
• Review the investigation of Out of Specifications, Out of trends, Lab events, Recall, FAR, PQC, Deviations or any other specific investigation, as needed.
• Responsible for identification and preparation of Best practice Guide documents to enhancement of Lab efficiency/Error reduction.
• Responsible for monitoring the implementation of all approved BPDs at sites,
• Ensure effectiveness of BPDs are monitored through trending of Lab Events & OOS/OOT and identify improvement areas
• Ensure consistent and flexible approach towards global regions time zones and travel if required to conduct lesson learned.
• Maintain a working knowledge of EDMS, LMS, Track wise and other software\xe2\x80\x99s relevant to the day today activities.
• Performs all work in accordance with established regulatory and compliance and safety requirement.
• Responsible to conduct trainings for SPQC programme.
• All other duties as assigned by reporting manager.

Requirements and Qualifications:
Basic Qualification:

• M.Sc. Organic Chemistry

Industrial Experience & Knowledge:
10+ years of experience in the area of Quality control, Analytical development, Development Quality Assurance and corporate quality compliance.

• Quality system development and Implementation
• Investigations review.
• Analytical method validation and transfer activities