Piramal Enterprises Ltd. (PEL) is the flagship company of Piramal Group and has a leading position in the business verticals it is present in i.e. Healthcare and Financial Services
We forayed into the health care space in 1988 with a move that was contrarian at that time, as most pharmaceutical players were exiting India due to the existing business climate. It has been 25 years, and we have established ourselves as one of the most recognizable and respected names in the pharmaceutical industry.
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Today, we have manufacturing bases across India, UK, Scotland, the USA, and Canada through subsidiaries. Our critical care products are available in the emergency rooms of hospitals across the globe and our products are available in over 100 countries. We are presently the third-largest player in the global Inhalation Anesthesia (IA) market and the only company in the world with a complete product portfolio of Inhalation Anesthetics drugs.
Our manufacturing capabilities make us one of the largest custom manufacturing companies in the world. The ‘UN Conference on Trade and Development’s World Investment Report 2011’ ranks us among the top 5 in the world.
Through the years, we at Piramal Healthcare have partnered with the largest and most reputed organizations in the global pharmaceutical industry to expand our product offering and deliver the best innovations to our customers.
Position: Chief Manager – Corporate Quality Compliance
Location: Vikhroli, Mumbai, Maharashtra, India
- 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 the 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 site visits or audits conducted by clients or regulatory/accrediting agencies.
- Plan and execute the 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.
- 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 for 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.
- 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.
- 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.
- 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.
- Ensure market complaint investigation and recalls are executed by the site team thoroughly and timely. Facilitate the process and ensure compliance with procedures and associated metrics.
Desired Candidate Profile
- Well-organized and detailed oriented professional, with strong verbal and written communication skills, as well as should have experience of technical writing
- Hands-on experience implementing quality systems in a GxP environment, and direct experience with FDA, MHRA, and other health authority inspections
- Extensive knowledge of US GxP compliance regulations and industry practices, as well as EU GMP requirements
- Strong technical understanding with the ability to analyze & report complex information
- Strong in problem-solving with the superior investigation and interview skills
Qualification: B.Pharma & Above
Experience: Minimum 15 Years in Pharma Regulated Facilities & Min 5 Years in Injectables or OSD’s