Sun Pharma
Join to apply for the
Manager, Quality Compliance
role at
SUN PHARMA Description
Manage all routine activities of Quality Compliance functions to ensure overall compliance with FDA current Good Manufacturing Practice (cGMP) regulations related to testing and release of drug substances, components, and packaged products. Ensure plant-wide compliance with cGMP standards in collaboration with and as directed by the Site Head - Quality. Provide backup to the Site Head - Quality in their absence. Job Responsibilities Manage routine Quality Compliance activities to ensure compliance with FDA cGMP regulations for testing and releasing drug substances, components, and packaged products. Ensure plant-wide adherence to cGMP standards under the guidance of the Site Head - Quality. Oversee the flow of drug substance components through the Quality Control Laboratory for raw material and bulk product release. Conduct job-specific training for all Quality Control laboratory and Quality Assurance personnel involved in testing and release processes. Implement cGMP training programs for all relevant personnel. Participate in FDA facility audits. Coordinate with purchasing departments on quality issues related to intermediates, raw materials, or APIs. Collaborate with processing, manufacturing, and analysis groups. Work with IT to ensure compliance with cGMP and FDA expectations. Develop and maintain training programs for Quality Assurance and Quality Control staff. Manage the department's operating budget and support quality assurance initiatives. Assist in laboratory analytics, including volume analysis, deviations, OOS investigations, and metrics. Stay informed on compliance initiatives relevant to the department. Participate in site audit teams and inspect contract suppliers. Review and approve investigations of laboratory out-of-specifications and drug substance failures. Review and approve quality documentation related to environmental monitoring, cleaning, calibration, and equipment maintenance. Support regulatory agency inspections and collaborate with customers to monitor quality systems. Serve as backup to the Site Head - Quality. Perform other duties as assigned.
Requirements
Advanced degree in Chemistry or a related field with at least 5 years of experience in quality assurance/control. Minimum of 5 years of QA/QC experience in a cGMP/API environment. Previous management experience. Proficient in Microsoft Office programs: Word, Excel, Access, PowerPoint. Proven track record of compliance improvements.
Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr
Manager, Quality Compliance
role at
SUN PHARMA Description
Manage all routine activities of Quality Compliance functions to ensure overall compliance with FDA current Good Manufacturing Practice (cGMP) regulations related to testing and release of drug substances, components, and packaged products. Ensure plant-wide compliance with cGMP standards in collaboration with and as directed by the Site Head - Quality. Provide backup to the Site Head - Quality in their absence. Job Responsibilities Manage routine Quality Compliance activities to ensure compliance with FDA cGMP regulations for testing and releasing drug substances, components, and packaged products. Ensure plant-wide adherence to cGMP standards under the guidance of the Site Head - Quality. Oversee the flow of drug substance components through the Quality Control Laboratory for raw material and bulk product release. Conduct job-specific training for all Quality Control laboratory and Quality Assurance personnel involved in testing and release processes. Implement cGMP training programs for all relevant personnel. Participate in FDA facility audits. Coordinate with purchasing departments on quality issues related to intermediates, raw materials, or APIs. Collaborate with processing, manufacturing, and analysis groups. Work with IT to ensure compliance with cGMP and FDA expectations. Develop and maintain training programs for Quality Assurance and Quality Control staff. Manage the department's operating budget and support quality assurance initiatives. Assist in laboratory analytics, including volume analysis, deviations, OOS investigations, and metrics. Stay informed on compliance initiatives relevant to the department. Participate in site audit teams and inspect contract suppliers. Review and approve investigations of laboratory out-of-specifications and drug substance failures. Review and approve quality documentation related to environmental monitoring, cleaning, calibration, and equipment maintenance. Support regulatory agency inspections and collaborate with customers to monitor quality systems. Serve as backup to the Site Head - Quality. Perform other duties as assigned.
Requirements
Advanced degree in Chemistry or a related field with at least 5 years of experience in quality assurance/control. Minimum of 5 years of QA/QC experience in a cGMP/API environment. Previous management experience. Proficient in Microsoft Office programs: Word, Excel, Access, PowerPoint. Proven track record of compliance improvements.
Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr