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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
Senior Executive - Quality Control
Job Description
Position for Quality control Analyst Role having 4-6 years experience
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Responsible to maintain the laboratory as per good laboratory practices, good documentation practices, 21 CFR guidance and meets cGMP Requirement.
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Responsible to adhere with data integrity policy, ALCOA++ principle during performing any activity inside the company premises.
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To follow the administrative policies including personal hygiene, HR procedures, environmental and safety regulations within the site premises.
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To identify unsafe conditions/ acts inside the laboratory, report to supervisor/ HOD- QC and ensure its completeness.
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Responsible to keep Lab and Instruments neat, clean and in working condition all the time.
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Timely communicate any abnormalities observed during analysis and escalate it to supervisor for appropriate action.
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To ensure the analysis activity perform in the laboratory by following approved procedures.
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To ensure the training on the activity which are assigned by supervisor/ HOD-QC prior to execution.
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Actively involve and participate in assessment, investigations, and implementing CAPA effectively.
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Responsible for Internal & External vendor follow-up and timely completion.
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Responsible for maintain the minimum stock and Use valid working standards, reference standards, impurity standards, chemicals, reagents, glassware and solvents required for analysis and Ensure availability as and when required
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Responsible for sampling activity and Control sample Inspection.
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Perform Sampling & analysis of packing materials, raw materials, stability samples, in process and finished products.
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Responsible for analysis of test parameters includes description, solubility, Water content, Purity/ related substances by GC, Assay by GC etc.by using approved testing procedure.
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Responsible to perform and complete the work assigned by supervisor/ HOD-QC/ Head-Quality as and when required.
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To receive the analysis sample includes packing materials, raw materials, In-process, Intermediate, API, finished product samples and make entry in to the respective AR number logs.
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To initiate the analysis as per work allocation done by supervisor/ HOD-QC of these samples for test parameters includes description, solubility, Water content and other chemical analysis and non-Chromatographical methods of wet laboratory section.
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To execute the analysis activity by completing all necessary documentation related to instrument logbooks, analytical test report, analysis worksheets, analytical hard books and document archival after approval of samples.
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To perform the wet lab instrument calibration as per the schedule and respective SOP as and when required.
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To execute the chemical analysis of additional studies like stability study, method validation/ verification study/ any investigation purpose analysis.
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Destruction of samples after approval and subsequent record to be updated.
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To ensure the availability of valid working standards, impurity standards, reference standards and its management during usage.
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To Support to maintain GC columns within the laboratory and ensure the stock availability.
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Report any non-conformance i.e. Laboratory Incidence, OOS/OOT/OOC to Immediate supervisor for further action.
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To preparation of dispatches COA’s i.e RM,PM API, IMT and Finished etc..
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Bachelor of Pharmacy (BPharm), Bachelor of Science (BSc), EnglishFinished Products, Quality Control (QC)
