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Associate Director NJ Open (J#45649) Title: Associate Director Company: Scientific Search Description - Periodically audit the DF Manufacturing operations to ensure the cGMP compliance all the time - Review the electronic and paper data generated by DF Manufacturing as well as analytical labs as soon as the activity is completed. Follow up with respective departments for execution of data on time and ensure the data integrity of all the documents ready for submission. - Critical review of any analytical as well as manufacturing deviations or non-compliance issues related to : - Process and Analytical method transfer documentation - Development report prepared by DP manufacturing site - New Abbreviated New Drug Applications (ANDA) - Supplemental Filings e.g. site variation, CBE or Prior Approval Supplements - Accuracy & integrity of Annual Updates of existing approved ANDA s and NDA s - Drug Product stability program - Process Validation of commercial Drug Products - Work planned by self 60-75% - Work planned by others-25-30% Conduct announced or unannounced pre-submission audits in such a way that it includes an audit trail to demonstrate the complete transparency & ensure the integrity, trustworthiness and reliability of DF manufacturing generated records are well maintained all the time. Critical review of all electronic and paper documents as soon as the activity is completed. Inform the concerned department heads to complete the meaningful Deviation/investigation within the time frame laid down in respective SOPs. Inform immediately senior Management for any significant irregularities in the documents ready for filing. Maintain an audit trail and certifications that are maintained in paper or electronically available to FDA & retained as per company documentation retention policy. Periodically audit Ranbaxy DF manufacturing departments for data integrity. Coordinate with internal and external consultants for timely filing of ANDA s and ensure the expense remains within the approved budgeted numbers Train the staff engaged in Technology Transfers, Exhibit and commercial batch manufacturing of dosage forms for cGMP expectation of US FDA and other regulatory agencies. Ensure that each regulatory submission made to US FDA is diligently investigated for any deviations and the DF manufacturing generated data provided in the application is accurate & complete in all the respects. Ensure that electronic data generated at DF Manufacturing is archived systematically and can be retrieved immediately at any time with complete audit trail functionality. Assessment and Planning of Work Work load will be driven by number of new ANDA/NDA filings, Annual Reports, CBE and Prior Supplement filings in a particular year. Areas where decision is made independently: 55-60% Areas where decision is made in consultation with others: 25-30% Areas where decision are delegated to a higher level: 15-20% Problems/ Key Features - Maintain adequate operating controls over a complex time bound critical compliance activities. - Defining and prioritizing the program risks and developing time bound mitigation plans. - Ensure work alignment with priority and close interaction with R&D, PDL, Plant Manufacturing and quality unit. - Assigning responsibility for day-to-day project execution to project Mangers & challenge team members/stakeholders to deliver on time the right quality product in a demanding environment. - Provide accurate, timely, and visible reporting to program stakeholders Ability to interface with the head of DF Manufacturing, Plant Quality Units, Regulatory Should also feel comfortable in communicating with Consultants/Contractors Quality Unit FDA/Legal counsel Requirements - Strong understanding of cGMP requirements of US FDA laid down in current 21 CFR Chapter 210 & 211 et.al. - Expertise in Dosage Form manufacturing processes and technology transfer. - Hands-on experience in quality-by-design and design-for manufacturing principles. - Knowledge of manufacturing management practices - Understanding of pharmaceutical manufacturing, supply chain, and quality (QA and QC) operations. - Knowledge of cGMP and regulatory requirements of major markets. - Skilled in problem solving and risk mitigation. - Ability to direct a team of cross functional, cross-site resources to deliver results acceptable to regulatory agency. - Subject matter expertise related to quality assurance, regulatory affairs and third party certification - Strong written/verbal communication skills - Strong interpersonal & conflict resolution skills to facilitate collaboration amongst a diverse set of internal/external stakeholders to deliver results as per expectations of regulatory agencies. - Ability to drive the time bound tasks and remain focused under ambiguous & complex situations - Should have ability to influence and build credibility with internal as well as external stakeholders Educational Qualifications required for the job Master s Degree in Chemistry or Pharmaceutical Sciences Years of Experience required for the job 10-12 Years of experience in Pharmaceutical Industry out of which min 4 years of strong skill to Review the data ready for submission as well as analytical data including electronic format Interested candidates should submit current resume along with salary history to . For a faster response please include job code in subject line. Please note that all candidates applying must have proper US work authorization, client will NOT sponsor.

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