Posted on Apr 6, 2021 by Dr. Reddy's Laboratories Ltd
This position is based in Middleburgh, NY.
Design new additional quality systems ( eg Risk management), provide input for new strategic initiatives and lead the implementation of such initiatives at the site, approve critical plant specific standard operating procedures, review and analyze trends of investigation reports, lead the implementation of new strategies for any improvements in systems and processes in order to incorporate best practices in the field of quality and make quality processes more effective and efficient.
Collaborate with Regulatory Agencies (FDA, DEA, etc.), Middleburgh Administration, Engineering, Production and Safety. Provide quality systems and guidance, Quality Review updates, Collaborate with counterparts at NAG sites in order to create consistent compliant Quality Systems across NAG. Facilitate internal and external audits, responses, tracking and closure of audits.
Prepare action plans for customer and health authority audits and share with all stakeholders, interact with auditors and respond to their queries, review compliance reports for products, provide input for audit response report, respond to customer queries received through marketing or RA teams, act as a single point of contact for QA related activities for all overseas offices in order to ensure successful audits by customers and regulatory authorities.
Ensure training is provided to the site on cGMP topics(Orientation and Annual), including Data Integrity, conduct goal setting, performance appraisals, coach employees, participate in recruitment and induction, identify training needs based on future plans and business requirements, provide training on specific capabilities to team, identify and recommend retention plans in order to motivate team so that they could contribute to the achievement of business targets.
Participate in weekly cross functional team(QA, QC, Warehouse) meeting for development, exhibit, and commercial products to resolve critical issues related to products, resolve any non-compliance or pending issues and make decisions on disposal of batches, participate in weekly review meetings (site director, QC, QA, production) to plan for future actions for upcoming products, participate in monthly cross functional meetings to present issues faced by QA to other teams, participate in periodic Quality Review Meetings of all plants with entire quality team to share knowledge and best practices, provide input for quality improvement plans, present details of market complaints to various teams for every quarter which include details of deviation, out of specifications and incidents in order to ensure smooth information dissemination amongst cross functional teams and maintain quality for development, exhibit and commercial products.
Review incident investigation reports and make final decision on batch rejections eg out of specification, out of trend etc, suggest corrective and preventive actions to prevent rejection of future batches, review and make final decision on "out of specification" rejections, debottleneck all product related issues and escalations by coordinating and influencing other teams eg production, RA and QC etc., approve all major and critical change controls and planned deviations, guide team in root cause analysis in order to ensure that incidents are dealt with as per standard operating procedures and within prescribed timelines.
Review and approve critical validation documents (validation master plan, site master file, SAP Validations), review and approve validation protocols and validation reports prepared by team in order to ensure that the validation process is executed as per plan for each product.
Education Required: Masters or Bachelors Degree
Years of Experience: Minimum of 10 years