Senior QC analyst

at  Piramal Enterprises

Key Roles/Responsibilities:

• Execute analytical procedures, for testing of raw materials, in process products, bulk drug substance, final products and stability products according to defined by SOP´s, and protocols and ensure that the QC team is in compliance with the same.
• Apply best cGMP work-practices and techniques to test and release raw materials, in process products, bulk drug substance, final products and stability products within specification
• Ensure that all QC analysts are appropriately trained and competent in the procedures they are conducting, and are in compliance with best cGMP working practices at all times.
• Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data provided by the QC Analysts
• Immediately escalate and report any deviations to materials, facilities, processes or procedures to the QC Manager
• Be accountable for the analytical laboratories being clean, tidy and well organized and in a state of continuous inspection readiness.
• Conduct all activities in the most careful and safe manner and in full compliance with ESH requirements
• Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards.
• Issue, manage and close-out deviations, change controls, OOS or SST investigations and CAPA´s in a timely fashion
• Identify areas for continuous improvement and escalate those to the QC Manager.
• Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting.
• Support installation, qualification and periodic review of equipment.
• Support the transfer of new methods and techniques into Quality Control.
• To undertake any other duties as requested by the line manager in accordance with company requirements

Competencies:

• Highly organised
• Effective communication
• Ability to motivate and organise a small team
• Attention to detail
• Understanding of scientific and technical processes
• Problem solving
• Investigation of deviations

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

• Execute analytical procedures, for testing of raw materials, in process products, bulk drug substance, final products and stability products according to defined by SOP´s, and protocols and ensure that the QC team is in compliance with the same.
• Apply best cGMP work-practices and techniques to test and release raw materials, in process products, bulk drug substance, final products and stability products within specification
• Ensure that all QC analysts are appropriately trained and competent in the procedures they are conducting, and are in compliance with best cGMP working practices at all times.
• Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data provided by the QC Analysts
• Immediately escalate and report any deviations to materials, facilities, processes or procedures to the QC Manager
• Be accountable for the analytical laboratories being clean, tidy and well organized and in a state of continuous inspection readiness.
• Conduct all activities in the most careful and safe manner and in full compliance with ESH requirements
• Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards.
• Issue, manage and close-out deviations, change controls, OOS or SST investigations and CAPA´s in a timely fashion
• Identify areas for continuous improvement and escalate those to the QC Manager.
• Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team-setting.
• Support installation, qualification and periodic review of equipment.
• Support the transfer of new methods and techniques into Quality Control.
• To undertake any other duties as requested by the line manager in accordance with company requirement