Manager Dahanu Quality, ACG Capsules

Roles and Responsibilities -

• 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
• 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 site.

• 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
• 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
• Qualification - Bpharma/Mpharma/BSC/MSC and BE
• Experience - 12-17 Years in QA