- Developing analytical methods, validation and verification of QA test methods to proactively identify and execute optimization Improvements.
- Ensuring chemical, microbiological and physical testing for products, raw materials, packaging materials, buyout products, in-process materials, stability release test samples, bulk and/or finished products following strict customer, regulatory and accreditation standards.
- Evaluate the defined specifications and provide recommendations in order to ensure they are adequate to meet the quality standards, Recommending, leading and/or supporting investigation efforts related to manufacturing and/or laboratory deviations, out-of-specification test results, including the identification of root cause, corrective and preventative actions.
- Recommend approach on any critical variances/deviations in standard products - Relase Under Deviation and put up for Head Technical's approval Update, review and issue NTBU (Not to be used) guidelines as per product categories and seek necessary approval .
- Receive product complaints from the field (training team or ABOs) on standard forms, categorize as per classifications (packaging, etc.), take inputs from respective manager and provide response to the customer directly and others involved within the stipulated SLAs.
- Take decisions on QA approvals for non critical RUDs for raw material and packaging Modify, adapt and update quality assurance guidelines for contract manufacturer Conduct audits of contract manufacturers and critical material vendors to ensure company's quality standards are adhered and compliance to GMP requirements.
- Create the manufacturer wise Quality Assurance plan including details such as testing requirements, frequency, in house/outsourced, audit, frequency of audits, etc.
- Recommend process changes; lay down equipment specifications for QA aspects for existing contract manufacturers Undertake production trouble shooting for his area and provide suggestions and inputs for required change.
- Conduct stability studies as per the jointly created stability protocol approved by Head Technical and take appropriate actions for ensuring stability Provide inputs on regulatory matters related to quality.
- Interact with industry associations on laying down testing methods for the government for various product categories Interfacing directly and indirectly with customers and suppliers to determine testing requirements and to resolve method and/or specification issues.
- Monitoring testing trends and quality control data to drive continuous improvement.
- Providing mentoring, coaching and support to QA team,Participate in staffing activities; engage and retain team members, develop competencies in team members; guide & set KRAs in line with employee capabilities & organizational requirements; identify career developmental needs & take appropriate action in order to build an engaged and skilled workforce to deliver quality work.
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