Deputy Manager

Major Purpose Of The Job

• To ensure compliance of procedure and practices in line with GMP guidelines and regulatory expectations for concerned manufacturing facilities and products of Biotech division, Cadila Pharmaceuticals Ltd.
• To coordinate and ensure execution of validation/qualification activities
  

Principal Tasks And Responsibilities

 Ensure timely release of Drug Substance (Bulks) manufactured in Biotech Division Managing, mentoring and tracking activities of team, Troubleshooting of key issues and reporting to HOD and management Managing External as well as Internal Audit and Audit compliance related activities Ensure Training index/training needs and completion of Team Ensure timely revision of all QA related SOP and follow up of same of different department SOP Ensure documentation management control as per SOP QA coordinator in TIMS to upload SOPs and training questioners

• Review, Approval of documents:
  

 SOP’s, Specification(s), STP’s , MMD’s, Batch Manufacturing Records, Technology Transfer Documents, analytical data, method validation, stability protocols and internal reference stranded qualification
 Change controls, incident, deviations, investigation report, Audit Compliance, Risk Assessment, shutdown, CAPA plan and its Effectiveness Equipment qualification/Process validation/ cleaning validation/hold time study protocol and reports

• Coordination and Execution:
  

 To Ensure Execution Of Validation Activities Pertaining To

• Qualification of new equipments and Utilities (such as Water System, HVAC System, Pure Steam, Compressed Air)
• Periodic re-qualification of existing equipments and critical systems
• Area Qualification
  

 Coordination for execution of CAPA plan/risk mitigation plan and to ensure implementation of corrective and preventive action
 Coordination for tracking interdepartmental activities To supervise Execution of planner pertaining to qualification/validation and / preventive maintenance activities as per established schedule Coordination and Execution of self inspection plan Coordination with personnel from Pharma; manufacturing of sterile parental and QA for formulation and fill finish of biotechnological Drug Product (DP) Coordinate for Technology Transfer activities Coordinate for RM vendor qualification activity

• Review/Approval:
  

 Site Master file, Validation master plan, Halal manual and Quality management system manual
 To participate in cross functional activities as defined by HOD QA from time to time Any other job assigned by immediate superior/HOD from time to time