Officer- Quality Regulatory

Group Company- ACG Pharmapack Pvt. Ltd.- Primary Responsibilities- Strategic and planning- Establish compliance of certifications, product registration with regulatory bodies, performing regulatory testing to provide timely feedback to global customers.
- Achieve Operational efficiency by monitoring qualification and validation of equipment’s and instruments through controlled change management process to facilitate high quality products.
- Benchmark global target for ACG in terms of GMP in pharmaceutical primary packaging industry through periodic GMP audits of facility and conduct periodic GMP awareness trainings to all associates.

Core Functional
- Core- Ensure regulatory status of films and foils products by conducting applicable testing methods through external service providers.
- Liaise with consultants for DMF filings of products with regulatory authorities, annual updates and amendments of existing DMF, as and when required.
- Regularly monitor & update the documentation required as per ISO, Food Safety & GMP requirements and timely updating and/or amending the same followed by periodic review of SOPs, WI and other QMS documents to ensure system compliance.
- Prepare & maintain various documents (e.g., compliance certificates, LOAs, etc) required by customers with respect to the regulatory requirements & queries
- Ensure periodic Customer / certification Audit, ensure customer satisfaction & continuation of certifications by interacting and timely compliance to audit observations within stipulated timeframe.
- Ensure effective implementation of vendor quality management by scheduling supplier audits, review audit reports, compliance of Regulatory documentation & periodic updates for adequacy in coordination with Purchase Team.
- To ensure effective implementation of food safety management system as per responsibilities and authorities described in standard.

Internal Processes- Perform Self-inspections as per annual schedule,
- Ensure and monitor timely compliance and effectiveness of actions taken against internal/external audit findings.
- Prepare technical agreement for all raw material suppliers and service providers.
- Monitor qualification and validation activities of instruments, equipment’s and processes in line with validation master plan and validation procedure.
- Conduct periodic cGMP audits.
- Maintain control of documents in terms of generation, amendment, issuance and cancellation as per defined SoP.
- Key Result Areas- Compliance of customer / certification audits in agreed timelines for continuation of business and certification.
- Issuance of regulatory documentation and response to customer quires within timelines excluding new regulations.
- Monitor & track change management system with timely documentation and effective implementation & closure within timeframe.
- Ensure that the shop floor GMP practices are followed as per SOP to meet customer expectations on CGMP. Number of repeat instances of failure of GMP observations to be mapped to achieve the GMP score as per the internal score card norms.
- Review and upgradation of ISO (QMS, EMS, FSMS & cGMP) & Regulatory documentation by involving cross functional departments within timeframe as applicable.
- Carry out testing of films & foils as per the applicable test methods as part of regulatory testing through external laboratory, payment processing and preparation of complete and correct documentation as required for CFDA CDE / USFDA/ Health Canada registration. Annual updating of DMF registration.
- Prepare IQ, OQ, PQ protocol & report format, monitoring of Qualification, validation activities, equivalency studies for new as well as existing equipment’s and instruments, change in composition of product formulation on shop floor in co-ordination with user department.
- Key Interfaces**Internal Interfaces**:

- Planning
- Production
- Safety
- Human Resources
- Purchase
- Development & Technology
- Sales
- Business Development
- Operational Excellence
- Engineering.

**External Interfaces**:

- Certification Agencies.
- Regulatory Agencies.
- Customers.
- Suppliers and service providers.
- Educational and Experience Requirements- Graduate in Pharmacy/Plastics / Chemistry with 6 to 8 years of relevant experience.**Preffered**:

- Postgraduate in Regulatory affairs
- Certified ISO Lead auditor
- Technical Competencies & Personas- worked on change control or Validation/Compliance roles in an organization to ensure CSV compliance / process compliance- Regulatory & Risk Management- Customer and Supplier Management- Handling ISO Audit, Supplier’s Re-Evalution and Aesthetic Audit- Persona-Builder- Persona-Partner- Persona-Integrator