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Executive Quality Assurance
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#300006
Full Time
Job Description
Job Description
With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry.
Position Purpose:
Candidate should have skilled in manufacturing process of solid dosage form to ensure the compliance inline requirements of cGMP at shop floor.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Ensure and coordinate that QA activities are being done as per laid down procedure. To ensure that Production adheres to GMP standards, procedures, and systems in all respects of manufacturing including storage. Monitoring of product quality, in-process control, and manufacturing environment. Ensure effective implementation of the Quality system and procedure as per cGMP requirement at shop floor, warehouse, and engineering along with documentation. Investigation of the complaint, deviation, and OOS to ensure appropriate root cause analysis and CAPA plan.
• Review all BMR, and BPR for their correctness and retention until destruction. Review of quality records in a periodical basis and review of analytical data in COA. Issuance of BMR, BPR, Cleaning checklists, Logbook, and Labels as per requirement.
• Sampling of FG control samples, stability samples and other samples as per requirement along with related documentation. Responsible for alarm review and trending as and when required.
• Training of new employees, system practices and procedure to develop competency. Review and approval of executed batch manufacturing, packaging documents & other quality documents. Handling of material on shop floor through approval for MRN, LRN, and MRQN.
• Submission of In-process analysis report from QC to production after review. Handling of non-conformance. Online stage wise BMR/BPR review.
• Handling of SAP & track wise activity as per Quality Assurance procedure. Approval of line clearance during product changes over/ Batch change over.
• To ensure the Environment, Health and Safety related activities are completed.
• To report near miss and incidences as observed as per EHS requirement. To ensure data integrity compliances at the site and while performing activities.
Diversity & Inclusion / EEO
Minimum Requirements
What you'll bring to the role:
• M. Pharm/B. Pharm. from reputed institute with more than 5 years of experience in a pharmaceutical company.
• Having good interpersonal skills and stakeholder management.
• Experience in Shop floor activities, QMS, Audit & Other GMP activities, Engineering services, Quality decision making, Knowledge of production systems, IT Applications & tools, TQM and related industry GxP standards and processes.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Join our
Novartis Group Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.
That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.
And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges.
Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Sandoz No video provider was found to handle the given URL. See for more information
With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry.
Position Purpose:
Candidate should have skilled in manufacturing process of solid dosage form to ensure the compliance inline requirements of cGMP at shop floor.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Ensure and coordinate that QA activities are being done as per laid down procedure. To ensure that Production adheres to GMP standards, procedures, and systems in all respects of manufacturing including storage. Monitoring of product quality, in-process control, and manufacturing environment. Ensure effective implementation of the Quality system and procedure as per cGMP requirement at shop floor, warehouse, and engineering along with documentation. Investigation of the complaint, deviation, and OOS to ensure appropriate root cause analysis and CAPA plan.
• Review all BMR, and BPR for their correctness and retention until destruction. Review of quality records in a periodical basis and review of analytical data in COA. Issuance of BMR, BPR, Cleaning checklists, Logbook, and Labels as per requirement.
• Sampling of FG control samples, stability samples and other samples as per requirement along with related documentation. Responsible for alarm review and trending as and when required.
• Training of new employees, system practices and procedure to develop competency. Review and approval of executed batch manufacturing, packaging documents & other quality documents. Handling of material on shop floor through approval for MRN, LRN, and MRQN.
• Submission of In-process analysis report from QC to production after review. Handling of non-conformance. Online stage wise BMR/BPR review.
• Handling of SAP & track wise activity as per Quality Assurance procedure. Approval of line clearance during product changes over/ Batch change over.
• To ensure the Environment, Health and Safety related activities are completed.
• To report near miss and incidences as observed as per EHS requirement. To ensure data integrity compliances at the site and while performing activities.
Diversity & Inclusion / EEO
Minimum Requirements
What you'll bring to the role:
• M. Pharm/B. Pharm. from reputed institute with more than 5 years of experience in a pharmaceutical company.
• Having good interpersonal skills and stakeholder management.
• Experience in Shop floor activities, QMS, Audit & Other GMP activities, Engineering services, Quality decision making, Knowledge of production systems, IT Applications & tools, TQM and related industry GxP standards and processes.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Join our
Novartis Group Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.
That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.
And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges.
Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Sandoz No video provider was found to handle the given URL. See for more information
