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At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Key responsibilities:
- Responsible for QA of QC activity related to QC SGO Dewas.
- Proactively assess quality issues in quality control labs of the site and ensure compliance in quality control labs.
- Support for all time readiness of the site QC for any internal and regulatory agency audits\inspections at any given point of time.
- Assist for continuous improvement of Laboratory documentation system to increase efficiency and CGLP/cGMP compliance.
- To track non-conformance results reported by laboratory and communicate significant concerns to the site QC Head/Designee and Head QA of QC / Designee to ensure that test results are not released.
- Review and approval of Change control, SOP, Specification, STP, ATP and GP etc.
- Freezing the old / superseded material code and effectiveness of revised specification / ATP in LIMS.
- Distribution and retrieval of control document viz. SOP, Specification, STP, ATP, GP, Log books etc.
- Periodic verification of actual activity performed v/s attendance.
- To review/approval of configuration specification documents.
- Identify and implement solution for improving existing site QA of QC systems and processes. Ensure availability of adequate SOP to maintain compliance with GMP requirements.
- Shared accountability with Site QA of QC head and Site Quality Control Head -Ensuring that quality of products are tested meeting all applicable GMP regulatory requirements and for ensuring the quality & integrity of all GXP data & documents generated.
- Facilitate internal and regulatory agency audits, ensuring that findings from site QC audits are understood, assessed and addressed site wise in a comprehensive manner.
- Adhere to the company’s policies & procedures.
- Support for tracking and handling QMS record related to QC e.g. OOS, OOT, Deviation and CAPA effectiveness related to QC and other QMS related activities e.g. Lab event, Change control etc.
- Lab compliance and verification of on line QC activity. Perform random shop floor inspection of laboratories to verify lab compliance, lab instruments’ software audit trail review on periodic basis and practices & procedural compliance verification.
- Responsible for comprehensive 100% review of both hardcopy and electronic analytical raw data of Finished Products, In-process, Raw Material, Packaging Material and Stability study report etc. along with associated audit trails for each batch prior to batch disposition for accuracy, reliability, consistency, and completeness.
- Review of analytical document audit trail to assess compliance and action as appropriate. Identify and implement solution for improving existing site QA of QC systems and processes.
- Ensure electronic signature of analytical document wherever applicable.
- To review and approval of Qualification documents (viz. Method Transfers, Reviewer Qualifications), Instrument or software related –IQ, OQ, PQ & SQ are executed as per the standard procedure and compliance to the global quality standard.
- To review and approve laboratory instrument/devices calibrations, Standards Qualifications, Volumetric solution records etc.
- To review and approve documents of Standardization, Reagents preparation & other qualification as per GLP requirements.
- Ensure that following requirement are meeting for raw material, packaging material, Finished product and stability samples prior to release of batch as mentioned below:
- RAW MATERIALS AND PACKAGING MATERIALS :
- To ensure review and release of Raw Material and packaging related data.
- To ensure usage decision of Raw Material and packaging Material being performed in SAP.
- To ensure compliance of sampling & testing as per approved procedure/schedule.
- To evaluate & approve the transfer of raw and packaging material from one material code/specification to another
- Retest/Expiry date extension in SAP and code transfer activity related to QA.
- FINISHED PRODUCTS:
- To ensure the review and release of Bulk, Intermediates & Finished Products related data.
- To ensure compliance of sampling & testing as per approved procedure/schedule.
- To ensure the transfer of Finished Products from one Market/ Specification to another as per regulatory requirement.
- To ensure the review of Cleaning Validation & Beta lactam containment monitoring study data.
- EXHIBIT & COMMERCIAL STABILITY:
- To ensure Exhibit Stability samples, Innovator samples, Process Validation, Multimedia related data are reviewed as per protocol and compliance to the requirement.
- To review and approve the stability study protocol to ensure current requirement.
- To review and approve the stability study summary report
- To ensure the review of Commercial Stability samples related data and approved as per stability protocol.
- To ensure that samples are charged and withdrawn as per approved procedures.
- To ensure the data reviewed with in proposed expiry and the testing was carried out within the specified timelines and that there are no deviations from the applicable SOPs during the entire stability program including sample management, testing documentation.
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Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!
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Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).
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