We are hiring! Join our team of enthusiastic professionals at Piramal Pharma Solutions – Pithampur, India.
Details below, click here to apply: https://lnkd.in/eby7V6E
- Department: QA
- Role: Executive
- Experience: 5 to 8 yrs
- Qualifications: B.Pharm, M.Pharm, M.Sc
Work Locations: Pithampur, Piramal Enterprises Limited,
- Key Roles and responsibilities:
- To assure & review quality system and to ensure the compliance with established standards.
- Ensure effective implementation of systems and procedures as per cGMP, GLP, ISO 13485 and other regulatory/customer requirements.
- Participate in risk assessment, provide risk-assessment tracking and other established mechanisms for risk assessment.
- Handling of various QMS related software’s like TrackWise, ENSUR and SAP.
- To represent QA department in external and internal audits including their compliance and responding to audit observations, customer queries related to QA and to ensure appropriate corrective actions based in audit findings.
- Participate in Quality Improvement Projects and their implementation.
- Handling of documentation related to self-inspection and to maintain the same as per procedure.
- Develop reports and analyses to document potential risks and gaps that need corrective action or preventative action.
- To impart training to team members/other concerned personnel/new employees on SOP’s and on job training.
- To update on regulatory requirement and implementation.
- To initiate change control for changes in documents as per requirements. Participate in review of Change Controls.
- To Review and Approve QMS like Deviation, Investigations, Change Control etc.
- To participate in the investigation of complaints related to quality of products.
- Site champion for QuEST. Assist in preparation and sharing MIS, QIP etc. with site senior team, corporate team and / or customer on timely basis.
- Monthly assessment of Warning letter, 483s and other regulatory observations within industry.
- Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.
- To ensure the EHS (Environment, Health and Safety) related activities to be completed on time and to support EHS activities as per requirement. To report near miss and incidences as observed as per EHS requirement.
- To ensure data integrity compliances at site and while performing activities.
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