Deputy Manager - QC

Piramal Pharma Ltd

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Division

Piramal Critical Care

Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title

Deputy Manager - QC

Job Description

Responsible for Labware LIMS Masters and Routine execution and trouble shooting, Interface issues resolution
Analyticla data Review, Investigation and Change controls and QMS activities.
Responsible to maintain the laboratory as per good laboratory practices, good documentation practices, 21 CFR guidance and meets cGMP Requirement.
Responsible to adhere with data integrity policy, ALCOA++ principle during performing any activity inside the company premises.

Responsible for LIMS.

To follow the administrative policies including personal hygiene, HR procedures, environmental and safety regulations within the site premises.
To identify unsafe conditions/ acts inside the laboratory, report to supervisor/ HOD- QC and ensure its completeness.

Responsible to keep Lab and Instruments neat, clean and in working condition all the time.

Timely communicate any abnormalities observed during analysis and escalate it to supervisor for appropriate action.
Actively involve during assessment, performing and supporting to investigations, deviations and implementing CAPA effectively.
Overall responsible for Internal & External vendor follow ups and completions within the timelines.
Responsible to procure and maintain the minimum stock for working standards, reference standards, impurity standards, chemicals, reagents, glass wares and solvents required for analysis and ordering as and when required.
Responsible to complete the work assigned and ensure the training on the activity which are assigned by supervisor/ HOD-QC prior execution.

Review of packing materials, raw materials, stability samples, in process and finished products data.

Review Qualification, Validation, Calibration data, Procedures, Protocol, Audit Trail on timely manner.
To identify unsafe conditions/ acts inside the laboratory, report to supervisor/ HOD- QC and ensure its completeness.
To receive and inward the analysis sample includes packing materials, raw materials, In-process, Intermediate, API, finished product, Stability samples and make entry into the respective AR number logs.
To allocate work of chemical and Instrumentation area and ensure timely completion of work. Ensure allocated work is in line with Analyst Qualification reports.
Review QC Logs, Incidences, Reports and ensure document archival after released of samples.
Ensure Control sample inspection and Leftover sample disposal after analysis.
Ensure Instrument calibration and AMC done as per the schedule.
Prepared and Revised SOPs, Specification and Procedure in line with Regulatory requirement.
To perform the harmony related activities.
Preparation and checked by of the COA’s for RM,PM,FP,API IMT and working standard etc..

Conduct Training on SOPs, Trending and any other relevant procedure.

Prepare Stability Schedule, Stability protocol and Report, Validation/ Qualification, Trending reports.
Involved in Investigation and Ensure effectiveness of CAPAs.
Perform SAP activity and Ensure closer of QMS before release of Batches in SAP.
Perform the result posting in SAP.
Check audit trail and escalate if found any discrepancies.

Initiation, Review and tracking the closure of quality management system (QMS) documents such as change control, CAPA management, OOS, OOT, Deviations, incidents etc.

Make available valid working standards, impurity standards, reference standards and ensure verification against Pharmacopoeia Catalogue and review consumption record for completeness.
Ensure GC properly utilized as per its efficiency.
Co-ordinate with intra department to streamline the activity.
Involved in the change control process for revision of GMP documents.
Additional job’s as may be assigned by Head of Department as on when required.