Curia

Role & responsibilities Checking of SOP Compliance. Preparation and Updation of the Site Master File . Preparation and Updation of Validation Master Plan QA SOPs preparation/Revision. Execution of product Disposition/dispatch activity. Tracking of SOP revision due of all departments. Issuance, retrieval and destruction of SOP controlled copies. BMR, BCR issuance, retrieval and review. Line clearance after change over in production areas. Monitoring of routine manufacturing activities. Handling of Change Control. Handling of Deviations. Assist HOD QA for any technical information needed, documents requirement so as to carryout smooth and consistent day-to-day QA activities. Filling customer questionnaire. Feedback giving to marketing related queries. Participate in customer and regulatory audits. Performing vendor/supplier audits. Performing Internal audits. Review of validation & Qualification documents. Preparation of Annual Product Quality Report & updating online trend analysis. Vendor Qualification activity. PR requisition in oracle. Verifying batch no. correctness in oracle before issuance of batch manufacturing records. GMP rounds. Retained documents management. All documents issuance, retrieval and review. Label, Seals procurement, Issuance, Control and Inventory Management. Day-to-day Coordination with all departments. Controlled Copies Issuance related to all departments. Preferred candidate profile Post Graduate in M.Sc with 6 to 8 years or relevant industry experience. Should be able to handle independently. Thorough knowledge of SOP preparation, validation and audits.

Curia is a global CDMO with over 30 years of experience successfully guiding clients through the complexities of drug discovery, development, and manufacturing. We offer services across Small Molecules, Generic APIs, and Biologics backed by deep scientific expertise and a robust global network of resources and capabilities. Our dedicated teams, combined with advanced technologies, enable us to be both flexible and scalable, accelerating the delivery of your product to patients. This role is based out at Global Shared Services Center. Curia’s Global Shared Services Center (GSS) is a multi-functional strategic service center that delivers word class business support services to Curia and its consolidated subsidiaries. In this Role Associate would be responsible for supporting the team on operations activities related to environmental monitoring and utilities reports per the deliverables/mandates. The individual hired will be expected to foster an environment of continuous improvement and assist/participate in initiatives that enhance operational efficiency and control. Responsibilities : Review, analyze and/or interpret data to generate the related documents and reports. Perform activities related to Environmental monitoring and utilities reports. Data trending: Collect data, use statistical tools (excel, other tools), calculate trends. Tracking: Use calendar, schedules by sites and ensure the Trend reports are made ready. Report drafting: Use templates and prepare reports for review to the senior associates or to the team manager. Alert level assessment reports to be prepared and reviewed. Water and Utility reports preparations and reviewed. Aseptic process and sterility assurance knowledge and other critical areas related to Microbiology. Manage deadlines with efficiency and a high level of accuracy, manage multiple deadlines and communicate concerns as deemed necessary. Follows Curia Quality policies and procedures. Ability to follow manuals and FDA and ISO guidelines for sterility assurance. Results Focus. Qualifications : B.S./B.A. or M.S. degree in Biology, Microbiology, Biotechnology or related field. 7-10 years of experience in the pharmaceutical industry (commercial manufacturing facilities within API and/or DP), with experience in Microbiology Quality Assurance. Experience of Shared Services strongly preferred (dedicated unit for the execution of specific operational tasks for the multiple business units within the organization). Strong knowledge of the pharmaceutical industry regulations applicable to API and Drug Product manufacturers. Have experience with qualifying, monitoring and/or gowning into classified Cleanroom areas. Have experience with Barrier/Isolator Technology. Are familiar with Compendial Testing (Bioburden, Endotoxin, etc.). Are familiar with Aseptic Techniques and cGMP practices. Good understanding on Good Manufacturing Practices, with practical experience on the field. Required Skills : Strong analytical skills, attention to detail, and the ability to work under pressure while managing multiple deadlines. Preferred Skills : Experience with statistical tools and familiarity with regulatory compliance in the pharmaceutical industry. Show more Show less

Role & responsibilities Creation of purchase request and material inventory. Attending the breakdowns related to chillers, AHUs, scrubbers, air compressors & Refrigerators. Planning & Execution of Validation activities of supply air & exhaust air in HRC & IKP. Maintenance planning and supervision for pumps/blowers/scrubbers/piping and plumbing activities. Responsible for Documentation and training. Assist with the project management of all related building changes and expansions, including any modifications/improvements to building systems. Annual Maintenance Contract (AMC) Works scheduling & execution Handling of mechanical installations with proper safety. Modification of Site drawings & Planning and designing of new projects in AUTOCAD software. Planning & execution of facility related works -building water tanks & scrubber tank cleaning. Preparation of BOQ for new projects / modification projects. Comply monthly audit points. Planning & Execution of painting activities for fume hoods & walls & lab furniture. Following safety and environment rules in the site/plant. Any other engineering services related activity assigned by the supervisor. Monthly water & outside bore water Bills Cross checking & finalizing. Trainings to the vendors towards safety work. Planning & scheduling the repairing activities inhouse which minimize the services of outside contractors. Spare part inventory management and planning and execution of repairing and maintenance activity with the approved budget Plan and execute week end works with proper safety. Train the technicians to use proper PPE Energy conservation like power management (Electricity). Focusing on energy conservation and implementation Maintenance of lab furniture and storage units Implement SOPs within the operations Coordination with purchase, Labs, HR, QA, Stores etc Preferred candidate profile Support to internal team and continues improvement planning CAD drawings updates MIS preparation HVAC Maintenance execution Internal Preventive maintenance execution

Role & responsibilities POSITION SUMMARY The primary function of the Environmental Health and Safety Manager will be to create a strategic partnership with department leaders to assist in identifying workplace safety and health risks and implementing control measures that align with site and corporate initiatives. The EHS Supervisor is responsible for knowing, interpreting, and appropriately applying all applicable federal, state, and local laws, statutes and regulations. MAJOR DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned Lead site audits, risk assessment activities and implement corrective action promptly to ensure company and regulatory compliance. In partnership with operational leadership, set up and maintain safety training programs in all applicable safety competency areas. Assure training is appropriately documented, reviewed constantly to assure compliance and timeliness and maintain appropriate written records/documentation of such training being conducted and reinforced. Perform facility safety audits to ensure company and regulatory compliance. Exhibit safety awareness and safe work practices. Preparation and presentation of safety training programs and orientation information. Test and inspect safety equipment such as eyewashes, showers, fire extinguishers, etc. Guide and promote safe work performance by enforcing safety policies, implementing safety campaigns, and training managers and employees in safe practices and first aid. Supervision of physical security. Ensure that the security for the building is functioning well at all times. Assist with the maintenance of the card entry system. Recommend and implement methods to increase the quality of products and/or services. Comply with federal, state and local safety regulation by interpreting standards, enforcing adherence to regulations, completion of regulatory documents and advising management on needed actions. Maintain all necessary records for the same. Disseminate Occupational Safety and Health Administration (OSHA) rules and regulations. Eliminate or minimize hazardous situations by developing and recommending safety policies and procedures to senior management. Watch for and report irregularities such as fire hazards, unlocked doors, etc. Notify emergency services in case of fire or if in the presence of unauthorized persons. Inspect and ensure that the ETP / STP / WTP are functioning well and all relevant standards are being met. Ensure that all waste material is stored / removed in a safe and timely manner. Notify higher management of any discrepancies that might arise. Assist with the maintenance of Personal Protective Equipment. Assis with the maintenance of MSDS library. Responding to and investigating incidents. Participate in self-development activities. Train and communicate the importance of safety to all the existing and new employees and be able to strongly recommend and influence safe work practices. Maintain inventory and oversee distribution of controlled drug substances as pertains to on-site use for scientific purposes. Ensuring all safety norms are adhered to when consignments are shipped out. Complete and file all federal and state documentation as required. Work closely with all scientific staff and all other departments of the organization. Fleet management pertaining to movement of man and material. Assist in the development of the annual budget and track performance against the plan. Willing to put in long hours, if required depending on exigencies. Writing reports and making presentations on safety and security to higher management. Perform other duties as may be reasonably assigned in the course of business Preferred candidate profile B.Tech Chemical Engineering/ M.Sc Chemistry with Min 10 to 15 years of EHS experience in Pharma Industry. Experience of EHS in R&D/Manufacturing pharma would be added advantage.