Job Description

This position shall be responsible for oversight, monitoring and compliance with all quality system at the site. This position shall be responsible for oversight cGMP compliance of drug products manufacturing, Quality management process and computerized system compliance at site.

Essential Job Functions: * Responsible for monitoring of all cGMP activities at site.

• As part of compliance team, implement, operate, monitor and maintain quality systems which enable operations on site to occur in an efficient manner and in compliance with Global Quality Standards and cGMP.
• Assist in monitoring and tracking of various compliance actions arises due to regulatory inspections and internal\customer audits.
• Review the Global CAPAs and assist in implementation at site level.
• Assist to author, change and update Quality procedures as applicable
• Assist in any Failure investigations conducted at the site.
• Co-ordinate between different departments to facilitate the implementation and closure of CAPA after effectiveness Check.
• Review and evaluation of SOP HR/Production Engineering and QC.
• As part of compliance team, to Review of procedures and validation deliverables related to computerized systems, Audit response reports, Technical agreement, SOPs.
• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Preparation and review of standard operating procedures.
• Review Regulatory Inspection observations and decide compliance strategy.
• Preparation & Review of Monthly Metrics Report & timely Respond to Regional/Corporate office.
• Provide support in execution and monitoring of remediation compliance through compliance verification of audit commitments,
• Co-ordination between different departments to facilitate the implementation and closure of QMS record (deviation, Change Control, CAPA, OOS/OOT etc.) with timely manner
• Assist for QRB meeting & escalation of GxP related issues during QRB. Follow -up for implementation of QRB commitments.
• Preparation/Review/Approval of documents as per site Quality procedure.
• Trending of data as and when required.
• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established regulatory and compliance and safety requirements
• Any other activity assigned by Head-Compliance as and when required.