Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Deputy Manager-QA
To ensure cGMP in Quality Control laboratory.
Review of QC / QA documents.
- To ensure cGMP in Quality Control laboratory.
- Review of QC / QA documents.
- Review and approve OOS, OOT, Incident, deviation and QC laboratory data and stability summary sheet.
- To prepare QMS (OOS, OOT, Lab Incident and Quality Event) Trends as per said procedure.
- · To review and ensure effective implementation of regulatory requirement,
guidelines and pharmacopeia changes like IP,BP,USP,Ph.Eur,JP etc.
- To review of QC laboratory records on periodic basis.
- To impart training to QC Laboratory personnel on SOPs, on-job training, regulatory requirements and
- guidelines.
- To ensure back-up of software data of all QC instruments.
- To ensure compliance of AMC/PM visit for all QC instruments.
- To ensure compliance of Qualification and calibration planner for QC instruments.
- To review QC Laboratory records (Issuance and archival of the documents like Laboratory note Book, Chromatograms, COA etc.).
- To provide Quest data on monthly basis to concern person.
- To perform self-audit of QC laboratory on periodic basis.
- To take the responsibilities of the activity in absence of immediate superior.
- To review audit trail for QC Instruments.
- To assign/disable password for QC Biometric system.
- Ensure compliance to KRA’s and other such assignments.
- Analytical and Electronic data review of respective batches at the time of release.
- Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related
- to Data Integrity awareness at site.
- Issuance and management of HPLC and GC column.
- Verification of admin audit trail along with IT person.
- To perform level-3 signoff for QC instruments wherever applicable.