Head of Quality Assurance

2 months ago

Kozhikode, India ACG World Full time

Objectives:

  • Implement cGMP compliance across the plant to meet regulatory requirement for business sustainability.
  • Implement QMS system compliance for adherence of process and product compliance as per regulatory norms.
  • Conduct Q&V of various equipment, instrument and processes at the plant


Primary responsibilities:

  • Review of APQR, audit response, all type of qualifications and validations, self-inspection, Change control, Deviations, CAPA, Incident report, OOS, VMP, SMF, customer complaint, Stability study, SOP’s, Training within timelines
  • Ensure timely batch release. Responsible & authorized for release.
  • Application for new additional Product, WHO Certificate, ISO, EXCiPACT certification, FDA Approval, Free Sale certificate. Liaison with various regulatory and accrediting bodies for obtaining the same.
  • Handle Customer, Regulatory and internal audit (self-inspection at the plant, GQA audit). This includes planning, execution, implementation of CAPA and closure of the same.
  • Ensure and drive the document (BMR, SOPs, Formats, etc.) control at the plant. This involves the system for issuance, traceability, up-dation, reconciliation, retrieval, archival is in place and review the same.
  • Preparation of Master Formula of all products as per License.
  • Ensure all the validation & qualification activities are implemented as per protocol and ensure execution of validation master plan.
  • Lead the investigation of customer complaint and provide response on the same with the support of other stakeholders (QC/Other Plant departments etc.)

Review deviations for RM, finished products and systems


Internal process:

  • Preparation and submission of monthly report (QMS related).
  • Quarterly review of product parameter (Trend analysis).
  • Provide data for monthly quality metrics


People Development:

Training and group discussion with colleagues to motivate them for organization benefit and individual development.


Key Result Areas:

Percentage of compliance on Customer and Regulatory audits

Qualification & Validation of equipment, process as per timelines

Adherence of equipment Calibration plan (for entire site)

Complaint resolution within timelines


Key Interfaces:

Operations

MSAT (TTT)

Technical Services

Scitech Centre

Q&RA

HR & Admin

Customers

External agencies/vendors

Pin bar manufacturing unit

Vendors

Service Providers

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