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, SOPs, 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
