Experience: 10+ years Notice Period: 30 days or Immediate Joiner Need a Cost analyst experience. Job Summary / Overview: This position will be a key business partner responsible for supporting the Sagent Finance and Operations teams in communicating key results, short & long-term financial planning, anticipating business issues, and driving good decision-making through sound financial management. This position requires a strong analytical background with the ability to support monthly close activities and leverage financial system tools. Candidate should be a self‐starter, able to demonstrate sound judgment and resourcefulness in decision‐making and problem solving. The successful candidate must also be able to think and work independently while also being a team player. The ideal candidate should have a minimum of 4-6 years of relevant experience as outlined below. Success Indicators: Strategic thinker with excellent analytical, critical thinking, problem-solving, interpersonal, and relationship building skills Ability to review and analyze financial statements with a solid understanding or financial concepts and applications Excellent ability to work with other members of Finance globally as well as other functions throughout the organization Excellent oral and written communication skills, including the ability to effectively present information and respond to questions Ability to define, implement, and adhere to policies and procedures Ability to work under strict deadlines Demonstrated ability to be a self-starter with the ability to think independently Experience working with JDE or a similar ERP system a plus but not required Key Duties & Responsibilities: Manage Jr. Cost Analyst, overseeing cost analyst work and development Analyze expenses and expense models covering actual, planned and expected costs to drive increased profitability Lead annual standard costing process preparing necessary templates, reports, and analyses to aid in setting standard costs Review and research reporting accuracy, perform in-depth root cause analysis as needed. Perform in-depth financial, variance, and trending analysis for key profitability drivers and metrics. Interpret results and articulate actionable recommendations to maximize profitability and ensure financial targets are achieved. Provide visibility to the financial impact of opportunities and risks arising during the quarter and ensure they are incorporated into FP&A’s Quarterly forecast. Support the creation of monthly and quarterly presentations focused on the internal operations of Sagent Strong ability to work in a team environment across Corporate Finance and Operations Minimum Qualifications / Experience: Bachelor’s degree in accounting or finance, CPA and / or MBA a plus 10+ years of related experience, preferably in a global complex organization Proficiency in MS Office – expertise in Excel, Access, financial modeling and scenario/sensitivity analysis Strong Analytical and financial modeling skills Proficiency in FP&A software – OneStream preferred Experience with ERP systems – JDE preferred  Sagent Pharmaceuticals i s an EEO/AA employer and does not discriminate on the basis of race, colour, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation. Show more Show less

Notice period: 1 Month Experience: 10+ Years Location: Hyderabad & Work from Office Job Summary / Overview: This role is primarily responsible for independently managing the development of labeling and managing key labeling systems and processes to support labeling development and approval at all stages of the product lifecycle at Schaumburg, Illinois and Hyderabad, India. Success in the role is measured on: Independently ensuring all project timelines and regulatory commitments are met for labeling at all stages of the product lifecycle, and with no disruptions to commercial availability of marketed products, driving measurable efficiencies and continuous improvements in labeling processes. No reworks, delays in launch or commercial availability or quality/regulatory impacts (recalls, etc.) Ability to understand and interpret regulatory requirements and translate this understanding into solid decision making. Ability to work within a flexible framework to meet all regulatory requirements from a design and content point of view in addition to meeting CMO and business requirements wherever possible. This position is a Subject Matter Expert, and does not have any Direct Reports. This position reports to the Director, RA Labeling. Any additional responsibilities as assigned by Regulatory or Quality Management. Key Duties & Responsibilities: 60% - Independently review and approve submission, launch and/or post approval commercial labeling in accordance with NDA/ANDA project goals, FDA requests and responses or commercial/business needs. This includes USPI, Primary, Secondary and Tertiary labeling. Ensure timely execution of shifting labeling priorities to balance all objectives and ensure all project timelines are met by interfacing with CMO’s and internal stakeholders. Review and approve, and at times proofread, all levels of labeling to ensure accuracy of regulatory and GMP requirements. Provide project support and manage labeling development process, including all design aspects. 20% - Develop, maintain and manage quality systems used in support of label development processes, including Label Master Index, Change Controls, File Management, NDC assignment and assessment, and SPL creation for drug listing, submissions, establishment registration and GDUFA. Daily work also includes knowledge of package engineering functions such as reviewing dyelines, barcode creation and maintenance, shipper labels, etc. 10% - Manage indirect labeling staff and hold members accountable for their responsibilities. Develop and guide indirect team members by assisting them in applying new skills, techniques and understandings. 10% - Develop and implement process improvements in label development and label maintenance to ensure continued operating efficiencies. Create/revise SOPs, work instructions, and guides accordingly. Knowledge or Experience: Understanding of the labelling lifecycle and direct pharmaceutical labelling experience. Understand context and content of label development. Proficiency in proofreading and impeccable attention to detail. Solid command of cGMP, FDA guidelines, and CFR labelling regulations/requirements required. Knowledge of patent/exclusivity carve-outs. Extensive experience in the use of PC- and Mac-based programs including Microsoft Office Word, Excel, Access, Adobe Acrobat Professional and Illustrator. Experience in document comparison software a plus. Previous use of working in Track Wise and SharePoint desired. Previous working knowledge of graphic design and the printing industry desired. Knowledge of SPL creation and Drug Listing/Establishment registration submissions, labeller code requests, regulations and guidance’s a plus. Solid understanding of DSCSA/HDMA regulations. Key Leadership Competencies: Builds strong relationships with peers and cross-functional colleagues outside of the core team in order to enable higher performance. Learns quickly in order to grasp onto the issues at hand and can change course when needed. Handles risk and ambiguity comfortably; ability to make high-quality decisions with less than perfect information. Ability to manage conflict and difficult conversations across all levels of employees in a constructive and transparent manner. Raises the bar and is never satisfied with status quo. Responsible for the overall well-being of the team/personnel. Encourages managers to develop subordinates. Encourages individual growth and development of employees by providing proper attention to personnel succession planning. Provide regular feedback to team members, in addition to completing annual performance reviews. Builds and maintains employee morale and motivation; fosters a diverse and inclusive workplace. Minimum Qualifications / Experience: 10+ or more years of direct pharmaceutical labelling experience or regulatory submission. The experience must have included decision making experience. Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects. Ability to prioritize projects independently / Experience working on project teams and leading teams. Ability to drive projects to completion with minimal oversight. Solid interpersonal communication skills (written and verbal) at all levels. Supervisory experience. Flexibility and strong negotiation skills. Thrive in, and be able to work in, a fast-paced entrepreneurial environment with broad responsibilities. Possess a broad career progression including experience in multiple departments in pharmaceutical, drug development or manufacturing industry. Have a passion for quality and an impeccable detail orientation. Education / Certifications: Bachelor’s degree required. Science background degree preferred (Biological, Chemistry, Pharmacy, Pre-Med, Nursing). Will also consider English, Journalism, Business, or Graphic Design degree. Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, colour, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.

Urgent requirement: Experience: Minimum 5+ years Location: Hyderabad (Work from Office) Immediate requirement Notice period: Immediate or 1 month Job Summary / Overview: Responsible for the execution of batch record reviews and associated product quality issue resolution. Authorizes shipments from Client contract manufacturing organizations (CMO) once all applicable documentation has been reviewed and deemed acceptable. Will provide direct support and guidance to new product launch initiatives and supply chain concerns. Ensure standards and requirements are met for all executed activities. Supports the existing quality systems, including executing SOPs and data management activities in association with the company’s management review process. Can interface with the company’s partners to clarify, assess, and/or approve product quality concerns. Key Duties & Responsibilities:  Review and approve batch records related to cGMP documentation- deviation and investigation reports, QC data, CoA, CoC, product labeling and specification sheets, and all documentation supporting shipment of products prior to shipment, including temperature profiling data. Provide guidance and support in all aspects of cGMP to our CMOs including in particular good documentation practices and root cause analysis during investigations.  Ensure all applicable data is accurate, up to date, and defendable to regulatory authority.  Provide ongoing support to the existing Quality Management System and training programs.  Write, review, or implement new standard operating procedures and policies, as necessary.  Participate on Global Alliance Management project teams to communicate quality concerns and team progress. Knowledge or Experience:  Excellent knowledge of current GMP and GLP as well as FDA trends guidelines.  Must possess exceptional communication and interpersonal skills.  Must have excellent organizational and project management skills to coordinate multiple projects.  Expertise in microbiology, aseptic processing, and terminal sterilization processes.  Possesses strong organizational skills for prioritizing workload and responsibilities.  Strong written communication, interpersonal, negotiations and problem-solving skills are required.  Ability to manage indirect relationships and projects successfully.  Proficient with PC – based word processors, databases and spreadsheets.  Attention to detail.  Elevates issues to management, when appropriate. Minimum Qualifications / Experience:  5+ years of experience in a Quality related position and knowledge of current GMP and GLP as well as FDA trends  5+ years of hands-on experience with Chemistry instrumentation including HPLC  Track Wise software experience preferred 2  Must have excellent organizational and project management skills to coordinate multiple projects  Strong interpersonal communication skills required – verbal, written and presentation.  Ability to work in a cross-functional team environment and a flexible team-oriented perspective  Travel not typically required or can be less than 5% per annum. Education / Certifications:  Bachelor’s degree in a Scientific related field Client is an EEO/AA employer and does not discriminate on the basis of race, colour, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation