- Ensure that batch production records are executed and reviewed in accordance with established SOPs and cGMP regulations.
- To release / reject the Batch after complete review of batch and related quality documentation.
- Conduct certification of BPR after completion of batch.
- Review and approve equipment qualification protocols and reports for accuracy, completeness, and traceability as well as adherence to protocol / procedures.
- Review and approve Annual Product review reports for the products as per the schedule.
- Track to completion all deviation and investigations related to product release.
- Conduct thorough investigations into and complaints for products manufactured at the site and ensure on-time closure of complaints.
- Run reports in electronic systems to ensure that all requirements related to batch release are met.
- Work directly with planning, QC, other QA functions, and Regulatory Affairs to ensure batches are released to meet supply chain requirements.
- Participate in self-audits of facility and equipment in partnership with Manufacturing and Engineering to ensure readiness for operations.
- Identify continuous improvement opportunities to increase compliance, process clarity, and operational efficiency.
- Review and approve Master Formula (Manufacturing / Packing Instruction) and SOPs.
- Review and approve process validation protocols and reports for accuracy, completeness, and traceability and well as adherence to protocol / procedures.
- Review and approve of QMS records in Trackwise system and ensure timely closure.
- To monitor timely initiation and completion of individual steps as per the work flow for all tackwise records.
- Provides appropriate training and development to support staff to meet their respective job responsibilities.
- Work in partnership with manufacturing, Engineering, and QC to increase knowledge and understanding of cGMP's and improve practices and procedures.
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Tender / Bidding Associate
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Dispatch Executive
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Senior Ads Manager
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Front Office Executive
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Web Designer
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Content Writer
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Sales Intern
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Online Bidder
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MotionGility Pvt. Ltd. Indore, IndiaWe are searching for a bid Associate to join our excellent team. In this role, you will identify opportunities for bid submissions, develop bid-winning strategies, conduct research, write and edit proposals, negotiate with stakeholders, and collaborate with other team members to ...
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Receptionist Male
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Social Media Intern
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Admin Executive
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Back Office Executive
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Accounts Assistant
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Shri Vile Parle Kelavani Mandal Indore, India**Mukesh Patel School of Technology Management & Engineering · **FOR THE POST OF PROFESSOR · - Essential: · a) Ph.D. degree in relevant field and First Class or equivalent at either Bachelors or Masters level in the relevant branch., and experience of ten years in teaching, resea ...
Senior Manager - Dewas, India - SUN PHARMA
Description
Job Description
Position: QA Manager
Department: Quality Assurance
Years of Experience: 15+ Years
Education: M.Sc. Chemistry
Job Role: Managing Quality Assurance functions in Block B/Production
Responsibilities:
