Manager

Department Icon Risk Management & Compliance
Posted: 7 months ago
0-1 years
India
Risk Management & Compliance
work from office
Full Time

Posted: 7 months ago
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Posted over 15 days ago, so the role may have closed. Confirm on the employer's page when you apply, or see similar jobs.

Job Description

  1. To ensure QMS and Audit compliances at Panoli crop manufacturing sites of Hikal Ltd.
  2. Establish, maintain quality system for effective functioning of Quality (QA & QC) Department and maintain within KPI.
  3. Establish Standard Operating Procedures (SOPs) / standard test procedures (STP)/ specifications for RM/PM/FG including in-process sampling plan, to maintain and improve organizational performance.
  4. Approval of Batch Production Control Records (BPCRs), Annual Product Qualification Report (APQR), Continued Product Verification Summary (CPV), Product Assurance plan (PAP), Contamination Prevention Risk Assessment (CPRA), Process Validation, Instrument/ Equipment Qualification protocol & reports and other documents.
  5. Review of new vendor analysis report & maintain record. Visit/Audit vendor facility for
  6. Reviewing and approval of finish product, In-process, intermediate & raw material product sample results as per SOP.
  7. Review & approval of reference standard development & its validation.
  8. Ensure the dispatches/ analysis of material as per marketing plan/business requirement.
  9. Approval of Purchase Requisition related to QC and QA department.
  10. To ensure appropriate investigation of customer complaints, audit compliance, OOS/, OOT,
  11. To ensure prevention of contamination and cross contamination activity.
  12. Ensuring the availability of adequate competent resources at quality unit to achieve the
  13. Process Improvement, Review new process & provide suggestions to the production process & achieve higher levels of quality at lower costs.
  14. Implement improvements as per the internal customer requirements, when required. Track
  • qualification.
  • Approval of analytical method development/validation/verification/transfer protocol and reports.
  • deviations and tracking for implementation of their RCA and CAPA.
  • departmental goal and contamination prevention objectives.
  • progress on process improvement programs that have been initiated.

15. Budgeting

  • Participating in projects team for feasibility evaluation and for new product implementation budgeting.
  • Keep own operations within allocated budget contribute to reducing quality operation cost

16. EHS

  • To ensure the proper filling of work permit system, safe handling of lab chemicals, samples, standards, use and availability of PPEs to avoid personal injury.
  • Follow safety procedures. Establish, Ensure & Supervise safe and good laboratory practices.

17. Knowledge Management & Capability Building

  • Ensure documentation according to statutory norms & other standards.
  • Responsible for developing quality consciousness & capability among all QC technical staff. Keep upto date with best practices in the industry & analyze the possibility of adoption & utilization of these at Hikal.
  • Lead the team of 10-15 People in QA/QC staff to get high performance along with speed and accuracy for the QA/QC activities .

18. Team and People Management

Authorities

  1. Approval/Rejection of material (Raw, Packing & Finish Goods).
  2. Access the QC laboratory, control samples and records.
  3. Recruitment of the QA/QC personnel for Panoli in coordination with Corporate Quality Head.
  4. Final approval for acceptance of any RM/ PM under deviation in coordination with business
  5. To grant leave to reportee and issue the gate pass to QA & QC staff.

and site Head.

Skills

AuditApqrAssuranceCapaCorporate QualityAudit ComplianceEquipment QualificationInvestigationOosOotProcess ValidationProduction ControlQaQcQmsProcess ImprovementSafetySopsStandard Operating Procedures

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