QA – Parenteral – G11A – Halol – I
- Location: Halol 1 – Quality Assurance
- Company: Sun Pharmaceutical Industries Ltd
- Education : M.Sc./B. Pharmacy/M.Pharrmacy/Engineering
- Experience : 10-15 years.
Responsibilities:
QA IT
Responsible to ensure GxP Computerized Systems at Halol site are in compliance with the current regulatory standards. (Computerized systems include Firmware based device, embedded systems, Process Control Systems- HMI/IPC, PLC/SCADA, Spreadsheet etc.).
Ensure implementation of relevant quality policies, standards and procedures for computerized systems.
Act as QA-lead for Validation of computerized system.
Ensure key documentation of computerized systems consistently meets the required quality standards throughout its lifecycle.
Review and Approve validation deliverables and lifecycle documentation for computerized systems.
Ensure the availability of the site CSVMP as per the quality procedure.
Ensure the availability of inventory of computerized systems and infrastructure, and ensure its compliance status.
Ensure the periodic activities as per the quality procedures are performed in a timely manner.
Provide support in the education and training of personnel in relevant areas of compliance and validation for computerized systems.
Review and approval of QMS (Deviations, Change Control, CAPA, incidences, investigations etc.) related to computerized systems.
Ensure resolution of identified risks/gaps related to computerized systems in a timely manner.
Mentoring and supporting site cross functions to resolve issues related to computerized systems.
Perform assessment /audit of suppliers / vendors of site computerized systems.
Perform the GxP computerized systems assessment and support remediation for ensuring 21 CFR part 11, EU Annex 11 readiness, adequate security and controls.
Work in partnership with the site cross functions and corporate functions for “Audit readiness” of computerized systems (for Validation and lifecycle management) for all internal/external and regulatory inspections.
Draft response and comply internal/ external audit observations for computerized systems.
Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives.
Lead to present/discuss and define way forward for fast track remediation of open action items related to computerized systems in site QRB meetings.
Technical competency required for Manufacturing process control system and laboratory based software system.
Perform other duties as assigned by Functional Head time to time.
Tasks:
He is authorize to sign as a reviewer and approver:
Computer system validation documents – MCS, IT Infra, Enterprise system, software based system and QC Systems.
Qualification Documents (Protocol and Report) – EFU.
Handling of any other activities / tasks allotted by department head.
HE is to authorize to sign (as Reviewer):
Master Document (SVMP, EQMP, SOP and Query Response etc.).
Qualification Documents (Protocol and Report).
HE is to authorize to sign (as Approver):
Qualification Documents (Protocol and Report).
Handling of any other activities / tasks allotted by department head.
