Documentation Manager

Job Description

development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.The RoleThe role is responsible to manager formulation development team/scientist involved in formulation development, process development and scaleup, Quality by Design (QbD), manufacturing process technology transfer and manufacturing process validation for various stages of formulation development under cGMP conditions.Key Result AreasRole-specific:

• Responsible for preformulation studies, formulation development, process development and technology for different types of formulations such as tablets, capsules, injectables, solutions and creams.
• Ensure that laboratory resources are optimized, while formulation development work meet the objectives required at each stage of drug development.
• Development of formulation as per internal and country specific regulatory guidelines.
• Responsible for reviewing and approving formulation data and reports in the CMC section of regulatory files.
• Facilitating scientific and technical discussions with team members and external collaborators to resolve issues and communicating conclusions.
• Participating with group members to explore innovative and improved ways for meeting the group s deliverables while contributing to the scientific depth of the group.
• Develop systems to design and author development reports using scientific and technical knowledge and in accordance with global stability guidelines to support clinical use and registration of small and large-molecule drug substances and products.
• Responsible for ensuring delivery timelines and adherence to customer quality and standards and customer relationship management.
• Responsible for Project planning, execution and revenue tracking of assigned projects.
• Responsible for proposal write up. Coordination with concerned department head for proposal writing and get it reviewed by them.
• Interact with clients and staff to develop strategies, interpret data and to guide analyses.
• Support to client and regulatory audit.
• Ensure that individual team member adheres and follows the systems and SOPs and provide training for the same.
• Responsible for ensuring cGMP and HSE related requirements within function.
• Possess the knowledge and exposure to Environment, Health, Safety, and Sustainability (EHSS) practices.
• Follow Environment, Health, Safety, and Sustainability (EHSS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on Environment, Health, Safety, and Sustainability (EHSS)

OTHER RESPONSIBILITIES:

• Build a highly talented team to drive successful integration of objectives. Coach and develop staff; engage in the recruitment, training and retaining talented scientific pool and provide cross-training wherever required.
• career advancement plans, objective / goal setting, deciding on the Goals & Objectives for direct reports and ensuring a similar approach for down the line reporting in the organization.
• Structure /improve processes and systems to ensure operational excellence in the organization.
• Direct and guide the team to engage in proposal writing, contract negotiation, sales presentations, support of client relations.
• As a part of leadership team, participate in formulating and reshaping strategies that affect Departmental growth, operations and future plans.
• Develop productivity metrics and initiatives to improve productivity year on year through combination of talent, processes and technology.

Keyskills :
sappackagingdeliveriesstorageinventoryqbasicinspectionfleetsevaluationwarehousingbasicrecordslogisticsmaintenancereportingcompliancedeliveryinventory managementwarehouse