Responsible for overall quality oversight, GMP compliance at assigned contract manufacturing sites.
Regular visits to contract manufacturing site to review the GMP and product compliance.
Manufacturing process monitoring / review of documents for product at contract manufacturing site.
Products stability management, document review and witness analysis of product under stability study at contact manufacturing site.
Finished product analysis for critical chemical (dissolution, RS & Assay) and physical quality attributes witnessed and review as per approved specification and method.
OOS, OOTs, deviation investigation, timely reporting, and support contract manufacturing sites in root cause analysis, finalizing CAPAs, their implementation and ensure effectiveness of CAPAs.
Change control documents, tacking, review and approval for changes made at contract manufacturing sites related to product, SOPs, facility, documents etc
Onsite investigation of market complaints along with site team for actual root cause analysis and monitoring of effectiveness of action plan along with closure of same in defined timeline.
Trending of market complaints; required action to be initiated in consultation with site QA head for repeated and critical complaints.
Audit observation timely response and support TPM in root cause, CAPA and on time implementation.
Responsible for effective and timely assessment and compliance for regulatory guidelines and Pharmacopeial changes.
Water & environment trend, MLT procedure & data of product / material analysis witness data & trends review, escalation for failure and ensure investigation, impact assessment and CAPA.
Raw materials, primary packing material & finished products to be reviewed with approved specification.
Review of APQR, trends of critical quality attributes for any significant shift and ensure implementation of recommendations, any need in process improvement in products.
Technology transfer support for initiation, process validation witness, document review for process validation, hold time study & stability study.
Support cross functional team in monitoring and review of process validation, analytical method transfer, analytical method validation and technology transfer activities.
Responsible for effective and on time review of FLQR documents, ensure product launch right at first time.
Responsible for coordination between Abbott quality management and site quality management.
To prepare the performance score cards of TPM s, Weekly, monthly report and ensure the compliance to the action plans provided by the TPMs falling in red / yellow category.
Participate and execute the allotted projects / assignments given by the Abbott HO and extend support to Zone lead / manager to other sites as per agreed timelines.
Accountable for effectiveness of Abbott SOPs and quality technical agreement at contract manufacturing sites. Escalate the concern timely to Abbott management
