Roles and Responsiblities   Identify, assess, and oversee compliance with legal requirements related to Environment, Health, and Safety (EHS) for API sites. Ensure efficient functioning of Zero Liquid Discharge (ZLD) systems and effluent treatment plants across API sites Provide guidance to sites for the adoption of global Environmental, Health, and Safety (EHS) standards, including interim actions.  Create operational and capital budgets for environmental expenses across sites, and monitor their implementation Coordinate and schedule regular meetings with stakeholders to discuss various aspects of the environment management system and safety management system Ensure adherence to ISO 14001 and ISO 45001 compliance requirements, including third-party audits Facilitate comprehensive Process Hazard Analysis (PHA) or HAZOP studies for all processes, ensuring the implementation of hazard study outcomes to enhance process safety Provide strategic guidance and mentorship to the team, fostering their professional development and enhancing their competencies Engage actively in accident and incident investigations, ensuring that corrective and preventive actions (CAPA) are promptly implement.  Create a strategic roadmap to enhance the existing Environmental, Health, and Safety (EHS) and sustainability management system, aligning it with relevant legal requirements, regulations, and international standards. Facilitate ongoing enhancement by assessing performance and delivering constructive feedback to management. Oversee EHS and sustainability compliance activities to ensure the efficient implementation of the EHS management system, policies, procedures, and programs throughout the organization. Continuously assess and review existing, new, and upcoming EHS legislation, rules, and regulations. Ensure that robust systems and procedures are in place to meet compliance and other requirements. Evaluate and enhance all facets of EHS policies and activities, ensuring consistent implementation across all projects Collaborate proactively with Project and Engineering Heads, as well as other key employees, to develop and sustain a program focused on continuous improvement within their respective areas of responsibility for Environmental, Health, and Safety (EHS) management. Establishing a comprehensive training and capability development system, which involves providing training, guidance, and coaching to the site EHS team to enhance their technical proficiency in Environmental, Health, and Safety (EHS) practices. Provide assistance and support to the site EHS team during presentations or meetings with regulatory authorities, as needed To ensure effective communication and alignment, regularly convene review meetings with the EHS teams across all sites. These meetings can be conducted through periodic site visits as well as teleconferences. During these sessions, discuss progress, address challenges, and strategize for continuous improvement in Environmental, Health, and Safety (EHS) practices Collaborate closely with the site EHS team to verify and uphold EHS regulatory compliance at each site. Additionally, provide guidance and assistance to the site team whenever necessary to enhance their compliance efforts Foster EHS awareness by establishing a competitive environment among sites. Regularly review and score each site based on their EHS performance using a culture meter score. Recognize and reward top performers to encourage continuous improvement.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"

Roles and Responsiblities Actively engage with R&D and act as the Stage Gate for products at the Engineering Batch and Submission stage of new product introductions. Create, promote and improve business and technical processes. Drive global standards for validation and product robustness across all the regions. Develop and implement a knowledge data base system to ensure that technical transfer activities are executed and summarized with appropriate results in approved reports to support regulatory filings and tech transfers. Should have knowledge of Product development expertise using QbD principles and expertise in evaluating the relationships between CPP and CQAs.  Expertise and skills to oversee Structured Root cause investigations and commercial trouble shooting including ensuring a right process is followed and CAPA identified.  Establish process monitoring and improvements at commercial manufacturing facilities and at Contract Manufacturing Organizations (CMOs) using scientific/technical concepts and techniques in collaboration with Site Technical leaders. Review and approve proposals for improved manufacturing processes, implementation of PAT and other tools that enhance process robustness and state of process and product knowledge. Skills in product scale changes and suggesting manufacturing modifications if required with a full 360 deg impact assessment to ensure faster and smoother implementation Deliver agreed financial targets such as departmental budget and key performance indicators   To coordinate with different departments i.e. Formulation Development, Production, Project Management, Quality Control, Quality Assurance, Packaging for the timely execution of the New projects (Exhibit batches) for solid dosage plants in India.  To oversee manufacturing of trial /scale up & exhibit batches, pre –launch/Characterisation batches & process validation batches for US, Europe, Canada, emerging and India market To arrange for the readiness of the New Product Launch at solid dosage plants in India To review & respond for process related regulatory query for exhibit batches. To review Justification/Investigation/Technical report for any event/incidence observed during the execution of the Exhibit batches. To investigate and support operation to resolve the Trouble shooting projects for solid dosage plants in India. To review Life cycle management projects like batch size increase, solvent reduction etc and provide technical support to Operation for implementation of same. To review site transfer documents and identify Gaps and support technical part to operation. To support operation and quality for alternate vendor qualification as per Global & site SOP. Identify and improve product robustness in collaboration with QA and production. To conduct weekly, Monthly and quarterly review meeting with all MSTG leads and key team members of all solid manufacturing plants in India. To conduct Monthly team huddle meeting with entire MSTG team of solid oral To participate in various regulatory audits to support plant. To contribute in Team building by imparting Training to teammates to upgrade capability Identification and evaluation of new technologies that can make SPIL competitive in manufacturing.   Qualifications Advanced degree in pharmaceutics or science or engineering with minimum 15 years’ experience in the pharmaceutical drug product industry is preferred; Ph.D. or other advanced degree with comparable industry experience is desired.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"

Responsibilities Characterization of RLD pack samples Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement Identification of new packaging material & new vendor development for packaging material Mold development for primary packaging material & secondary packaging material & its validation. Support to Regulatory team on ANDA’s/NDA’s filling for regulated market Coordination with NPI & planning team for launch of ANDA’s/NDA’s Preparation & revision of packaging material specification Preparation & review of MPC & FMEA Preparation & review of Development Study protocol & report & execute the study. Coordination with Cross functional team like FDD/RA/Plant/PPIC/Marketing/BD/PMO for completion of task Participating in FAT of machines Handling of Medical Devices, injectables and characterization. Preparation of Packaging documentation like Pack Style, Justification Report etc. as per Product/Regulatory requirements     Qualification & Experience B.sc / B.Pharm / M.Pharm with PG Dip in Packaging Development Experience : 6 – 14 years as a Packaging Scientist in Pharma R&D   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Development and implementation of Standard Operating Procedures (SOPs). Review and perform signal management activity as per guideline and SOP. Preparation, review & reporting of aggregate reports (Such as PADER, PBRER & PSUR) as per regulatory requirement with compliance to guideline & SOP. Oversight of in-house & out-sourced PV activities & maintain monthly compliance process. Ensure compliance (quality, procedures, regulations, timeliness, consistency) of aggregate reports, Signal management & all EU activities. Facilitate safety monitoring by optimising scientific quality documentation & data entry of safety case reports including spontaneous litigation reports. Management of ICSR activities as per respective regulatory requirements including safety data accuracy in safety databases. Responsible for partner/vendor audit and communication for all PV activity. Preparation and review of SDEA. Handling of RMP program in line with innovator for UK & EMA. Management of XEVMPD & SPOR databases with timely update safety variation in line with Art. 57 guideline.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Responsibilities Responsible to plan, co-ordinate and schedule the site visits for CAPA effectiveness review activities based on review plan. Responsible for CAPA effectiveness review associated with commitments provided to regulatory authorities across Sun manufacturing sites Responsible to review implementation status of "Global CAPA" across Sun manufacturing sites and track overall status of implementation of Global CAPA. Responsible to communicate CAPA Effectiveness outcome with site leadership for on time compliance and closure of identified non-conformance. Responsible to inform CAPA Effectiveness outcome to the higher management Responsible to provide Regulatory Audit Review Support to Sun manufacturing sites, need basis. Responsible for site compliance verification in-line with Sun Global standards and regulatory expectations. Responsible to identify the training needs and train site personnel as applicable to enhance overall compliance level based on site review / needs Strong organizational, administrative, interpersonal and communication skill Sound knowledge of current regulatory requirements/expectations and upkeep the team for the review activities Participate and support project work as allocated by reporting authority.   Qualification & Experience Graduate / Post-Graduate in Pharma - OR Equivalent 16+ Years of Experience. Highly preferable - experience in leading the evaluation, validation of CAPA activities and a strong knowledge / exposure to Regulatory Compliances & Regulatory Audits.  

Responsibilities Track and monitor site performance for improving quality index. Identify the key challenges and improvement areas. Discussion with site on action plan for improvement. Review of batch rejection, market complaint, FAR/Recalls, Invalidated OOS - Monthly tracking, review and collation of details and discussion with site Quality for action plan. To support site for audit readiness through discussion, site visit and providing reference documents to enhance compliance. To review audit compliance report. Update on status of Regulatory inspection, CQA audit and upcoming inspection on monthly basis.     Qualification & Experience Graduate / Post-Graduate in Pharmacy with 12+ Years of Experience in Pharma QC-QA.