Industry - Pharmaceuticals

Skills - Compliance, liquid injectable, oral liquid (bottling line)

Job Type - Permanent

Job Description

- Establish and deploy a quality compliance program; collaborate with key QA/RA stakeholders enterprise-wide to implement a standardized quality system built upon best practices from internal sites and outside industry standards.

- To understand the business & product needs with respect to system establishment and sustainability. In the process, it requires interactions with site functions and also assessing complexities of current processes.

- Ensure that the customer (internal and external) needs are understood properly and the services/products are delivered on time in full, from a quality function perspective.

- Lead, participate in or facilitate for site visits or audits conducted by clients or regulatory/accrediting agencies.

- Plan and execute Internal Audit Plan at Corporate. Ensure audits are conducted as per plan, issue reports in a timely manner and monitor the associated CAPAs to address the audit observations.

- Response to regulatory queries and deficiencies.

- Perform Forensic auditing / Data Integrity Audits / Routine GMP audits to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.

- Effective Aberration Handling (Review and Approval): Lead investigations for a variety of non-conformances which may include deviations, OOT, OOS, Batch Failure, Rejections. Identify appropriate SMEs, gather information/data, prepare investigation reports, and shape corrective/preventive actions to resolve recurring problems with permanent solutions.

- Manage Team responsible for the CAPA Process and provide leadership to address CAPA issues.

- Ensure market complaint investigation and recalls are executed by site team thoroughly and timely. Facilitate the process and ensure compliance to procedures and associated metrics.

- Prepare risk papers, position papers, conduct root cause analysis, propose and implement CAPA and risk mitigation plans for quality, compliance, existing business sustenance and business continuity.

- Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change management programs throughout the site/company.

- Improve quality compliance by recommending and following-up on improvement plans, training and contributing information to cross-functional quality improvement teams.

- Develop effective partnerships with internal staff and external organizations to facilitate problem-solving and resolution of issues.

- Prepare quality assurance reports by collecting, analyzing, and summarizing data and trends.

- Provide monthly KPIs and status reports on compliance initiatives to management.

- Coordinate with Site and Corporate team for Corporate Initiatives, improvising Long Term Quality Strategy.

Contact - Afrin Patel

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