Vacancy for Manager in Corporate Quality Compliance at Piramal Healthcare

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Piramal Healthcare Limited A major force in the pharmaceuticals and healthcare segment, Piramal Healthcare Limited, incorporating Healthcare Solutions & Pharma Solutions, has an unequivocal vision – to become the most admired pharmaceutical company, with leadership in market share and profits. Healthcare Solutions This is a division with a dream to build a differentiated and a profitable pharmaceutical business with a dominant share of market in each segment in which it has a presence. With a dream to transform the industry first in India and then globally. With a dream to penetrate every nook and corner of the country with modern medicine. With a dream to move beyond pharmaceutical product offerings and make an entry into healthcare services.

Post : Manager - Corporate Quality Compliance

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 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.

 

Candidate Profile

  1. Degree (advanced degree preferred) in Pharmacy.
  2. Skills: Leadership skills, Analyzing & Reporting Information, Technical Understanding, Decision Making, People Management, Dealing with Complexity, Problem Solving, Process Improvement, Investigation and interview skills
  3. Need to be ready to live and embrace the values of the company.
  4. Should be comfortable in short term and long term deputation at sites.
  5. Quality professional with 12+ years of experience in a regulated pharma companies.
  6. Atleast >5 years in dosage forms preferably liquid injectable or oral liquid (bottling line).
  7. Hands on experience implementing quality systems in a GxP environment, and direct experience with FDA, MHRA and other health authority inspections.
  8. Extensive knowledge of US GxP compliance regulations and industry practices, as well as EU GMP requirements.
  9. Well-organized and detailed oriented professional, with strong verbal and written communication skills.

Additional Information:
Experience: >5 years
Qualification: Degree in Pharmacy
Location: Mumbai
Industry Type: Medical / Healthcare / Hospitals
Functional Area: Quality Assurance
End Date: 30th October 2017

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