Apprentice

2 weeks ago


Telangana, India Piramal Pharma Solutions Full time

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.
- 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.
- To ensure the analysis activity perform in the laboratory by following approved procedures.
- To ensure the training on the activity which are assigned by supervisor/ HOD-QC prior to execution.
- Actively involve and Participate in assessment, investigations, and implementing CAPA effectively.
- Responsible for Internal & External vendor follow-up and timely completion.
- 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.
- Perform Sampling & analysis of packing materials, raw materials, stability samples, in process and finished products.
- Responsible to perform and complete the work assigned by supervisor/ HOD-QC/ Head-Quality as and when required.
- To receive the analysis sample includes In-process, Intermediate, API, Finished product samples and make entry in to the respective AR number logs.
- Initiate the analysis as per work allocation done by supervisor/ HOD-QC of these samples by using GC and Karl Fischer instrument technique.
- 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.
- 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.
- To perform the GC instrument calibration as per the schedule and respective SOP and qualification of GC instruments as and when required.
- To execute the GC analysis of additional studies like stability study, method validation/ verification study/ any investigation purpose analysis.
- Destruction of analysis samples after approval and subsequent record to be updated.
- To ensure the availability of valid working standards, impurity standards, reference standards and its management during usage.
- To arrange the GC columns within the laboratory and ensure the stock availability.


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