• Preparation and review all departments SOPS are for GMP compliance
• Implementation of cGMP practices at facility
• Preparation and review of Master BMR’s and BPR’s.
• Responsible for Product releases
• Preparation and review of Annual Product Reports.
• Review of specification, Standard Testing Procedures & General Procedures.
• Preparation of AHU validation Documents
• Preparation and review of APQR
• Review of Qualification documents
• Monitoring & control on vendor evaluation process
Handling of Market complaints by Investigation of root causes and implementation of corrective and preventive actions
Handling of Quality Notifications by Investigation and handling of Deviations, Non-conformances, Out of Specifications, Change Controls and CAPA Tracking.
Preparation of Training syllabus and training needs, Imparting training on shop floor and at contract manufacturing locations, Training modules & training calendars.
Preparation, review and execution of Validation protocols, summary reports and Validation activities and Technology Transfer Documentation.
Responsible for internal audits & compliance of the quality system to meet the GMP requirement.
Regulatory function & Operations of API manufacturing unit
Review the DMF / Registration Dossiers / TDPs of in-house developed APIs US, EU & Emerging Markets for accuracy of data, regulatory adequacy and completeness & prepare responses to regulatory deficiencies for expeditious approval.
Reviewing of DMF, GMP & Site accreditation documents for different countries and seek approval.
Strategy for amendments / variations for post-approval changes for smooth API Supplies
Reviewing of process packages from CRD and audited for adequacy from regulatory point of view.
Provide support to plant during time of audits of various Regulatory Agencies/customer.
Lifecycle management of APIs ensured by filing variations for post approval changes.
Keeping updates on regulatory requirements for submission of DMFs to regulatory authorities of various regions like US, EU, Japan, and Canada.
Review of pertaining documents of initial submission, supplement and amendment submission and deficiencies response.
Coordinate with R&D and Plant for drug product development/manufacturing, document generation and document correction.
Vendor selection and approval system
Coordinate with consultant for GMP inspection and drug product submission
Conduct and facilitate internal audits and coordinate and manage external audit schedules
Queries response to the regulatory agencies related with plant audits, correspondence and closing of findings