Manager (Quality Control)

Piramal Pharma Limited

13 - 17 years

12 - 15 Lacs

Hyderabad Zahirabad

Posted:9 hours ago| Platform:

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Skills Required

QC Compliance CAPA LIMS Investigation Change Control GMP

Work Mode

Work from Office

Job Type

Full Time

Job Description

Actively involve during LIMS deployment, act as LIMS admin, aware about CSV
LIMS data management, Mater data creator and static maintainer for LIMS.
Shall perform assessment, 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.
Responsible for completing assigned tasks and ensuring training on activities as assigned by the supervisor/HOD-QC prior to execution.
Review of packing materials, raw materials, stability samples, in-process data, and finished product data.
Review qualification, validation, calibration data, procedures, and audit trails in a timely manner.
Identify unsafe conditions or acts in the laboratory, report them to the supervisor/HOD-QC, and ensure appropriate action is taken to address them.
Receive and inward analysis samples, including packing materials, raw materials, in-process samples, intermediates, APIs, finished products, and stability samples, and log entries in the respective AR number logs.
Allocate tasks for chemical and instrumentation areas, ensuring timely completion. Ensure assigned tasks align with analyst qualification reports.
Review QC logs, incident reports, and other records, ensuring proper document archiving after the release of samples.
Oversee control sample inspection and ensure the proper disposal of leftover samples after analysis.
Ensure instrument calibration and AMC are completed as per the schedule.
Prepare and revise SOPs, specifications, and procedures in line with regulatory requirements.
Conduct training on SOPs, trending, and other relevant procedures.
Prepare stability schedules, stability protocols, and reports, as well as validation/qualification and trending reports.
Participate in investigations and ensure the effectiveness of CAPAs.
Perform SAP activities and ensure QMS closure before batch releases in SAP.
Actively participate during LIMS deployment, act as LIMS admin, and manage LIMS data. This includes master data creation and static maintenance.
Conduct assessments, support investigations and deviations, and implement CAPAs effectively.

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