Address- Handling of ENSUR system for issuance & retrieval of SOPs, specification, ATRs, work sheet & stability protocol management, BMR, BPR, BFR as on when required.
- Ensure the document control, archival, retention and destruction as defined in the procedure as on when required.
- Master and obsolete copies management for SOPs, specification, ATRs, work sheet & stability protocol, BMR, BFR, BPR etc.
- Tracking of SOPs, procedures, specifications etc. for revision as per the validity period.
- Responsible for archival management i.e. Archival and retrieval of documents as on when required.
- Login, review of the quality management system documents such as change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc.
- Tracking of all the quality management system documents such as change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc. till its closure.
- Monthly tracking reports for quality management systems as defined in the procedures.
- Handling product quality complaint (Adverse Event) and medical enquiry reconciliation tracker for Digwal site with Pharmacovigilance and market complaint investigations in CHEX system as per procedure in co-ordination with Pharmacovigilance team for adverse events as applicable
- Review & approval of investigation reports, risk assessment reports and to ensure the CAPA implementation, effectiveness assessment.
- Review the quality system documents such are protocols, reports, procedures, APQR, trend analysis reports, continual process verification reports etc. as on when required.
- Sharing the documents to the RA department for filing updation based on change control implementation.
Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.
PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.
Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.
Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.
