
Executive/Sr Executive- QA
1 day ago
Process Validation:
Plan and execute process validation activities for sterile injectable products as per cGMP and regulatory expectations.
Prepare and review validation protocols and reports, ensuring compliance with internal SOPs and global regulatory guidelines (e.g., USFDA, EU-GMP, WHO).
Cleaning Validation:
Develop and implement cleaning validation strategies for critical manufacturing equipment and facilities.
Review of cleaning validation protocols, analytical methods, and result interpretation to ensure carry-over limits are within acceptable criteria.
Hold Time Study:
Coordinate and conduct hold time studies for intermediates, bulk, and in-process materials to establish scientifically justified limits.
Review and trend hold-time data, identifying areas requiring optimization or revalidation.
Annual Product Quality Review (APQR):
Compile and review data for APQRs across product portfolios, analyze trends, and identify areas for continuous improvement.
Liaise with cross-functional teams (QA, QC, Production) to gather and verify relevant documentation and data.
New Product Introduction - Risk Assessment:
- Lead quality risk assessment activities for new injectable products, including impact analysis on facility, equipment, personnel, and processes.
- Participate in tech transfer meetings and review of validation and qualification documentation related to NPIs.
- Review and trend hold-time data, identifying areas requiring optimization or revalidation.
Annual Product Quality Review (APQR):
Compile and review data for APQRs across product portfolios, analyze trends, and identify areas for continuous improvement.
Liaise with cross-functional teams (QA, QC, Production) to gather and verify relevant documentation and data.
New Product Introduction Risk Assessment:
- Lead quality risk assessment activities for new injectable products, including impact analysis on facility, equipment, personnel, and processes.
- Participate in tech transfer meetings and review of validation and qualification documentation related to NPIs.
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Executive/Sr Executive- QA
1 week ago
Pithampur, Madhya Pradesh, India Gufic Group Full time ₹ 1,04,000 - ₹ 1,30,878 per yearProcess Validation:Plan and execute process validation activities for sterile injectable products as per cGMP and regulatory expectations.Prepare and review validation protocols and reports, ensuring compliance with internal SOPs and global regulatory guidelines (e.g., USFDA, EU-GMP, WHO).Cleaning Validation:Develop and implement cleaning validation...
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Sr. Executive/ Asst. Manager
1 week ago
Pithampur, Madhya Pradesh, India Altis Industries Pvt. Ltd. Full time ₹ 15,00,000 - ₹ 28,00,000 per yearDesignation: Sr. Executive/Asst. Manager - Accounts & FinanceResponsibilities:Manage GST compliance, return filing, ITC reconciliation, and handling of notices.Oversee TDS/TCS deduction, deposit, return filing, and reconciliations.Handle banking operations including fund management, reconciliations, LCs, and Bank Guarantees.Process vendor payments,...
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Sr. Executive/ Asst. Manager
2 days ago
Pithampur, India Altis Industries Pvt. Ltd. Full timeDesignation: Sr. Executive/Asst. Manager - Accounts & Finance Responsibilities: Manage GST compliance, return filing, ITC reconciliation, and handling of notices. Oversee TDS/TCS deduction, deposit, return filing, and reconciliations. Handle banking operations including fund management, reconciliations, LCs, and Bank Guarantees. Process vendor payments,...
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Sr. Sap Executive
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Executive
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Pithampur, Madhya Pradesh, India Lupin Full time ₹ 8,00,000 - ₹ 12,00,000 per yearJob Description Preparation & Review of SOP's of QA system and review / approval of SOP's of other departments.Review of master BMR/BPR of commercial and exhibit batches. Review of BMR / BPR, scale-up and placebo batches.Review of executed BMR/BPR of commercial and exhibit batches for batch release.Issuance, Retrieval & Destruction of SOP's, STP,...
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Quality Assurance Executive
6 days ago
Pithampur, Madhya Pradesh, India beBeequality Full time ₹ 4,00,000 - ₹ 6,50,000Job Overview:- Quality Assurance Executive.Key Responsibilities:Conduct quality inspections and operate CMMs to ensure adherence to specifications.Maintain product quality by verifying drawings and specifications.Implement IATF and ISO standards for documentation and inspection processes.Perform final dimensional checks and visual inspections as per drawings...
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Executive / Sr. Executive - IT
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Executive / Sr. Executive - IT
2 days ago
Pithampur, India Gufic Group Full timeResponsible for New computer Installation, Upgrades, software Installation, Hardware related support, Managing Inventory and providing the end support to users at site. Responsible for but not limited to, User management of software for creation, modification and disabling the users and assigning privilege groups as per the procedure defined in the...
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Executive / Sr. Executive - EHS
2 weeks ago
Pithampur, Madhya Pradesh, India Gufic Group Full time ₹ 1,04,000 - ₹ 1,30,878 per yearJob Responsibility:To file and coordinate for Health Safety and Environment related legal applications to obtain required licenses and permits from State or Central Regulatory Authorities such as Consent to Establish (NOC), Consent to Operate (CCA), CGWA NOC, Bio Medical Waste Authorization, Fire NOC, PESO Storage License as per requirements.To operate,...
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Executive / Sr. Executive - EHS
2 days ago
Pithampur, India Gufic Group Full timeJob Responsibility: To file and coordinate for Health Safety and Environment related legal applications to obtain required licenses and permits from State or Central Regulatory Authorities such as Consent to Establish (NOC), Consent to Operate (CCA), CGWA NOC, Bio Medical Waste Authorization, Fire NOC, PESO Storage License as per requirements. To operate,...