• Initiate the introduction of Formulation Development products by doing due diligence, gap assessment (Gap Analysis) and performing and reviewing all risks associated with introduction of new products • Carry out Formulation Development activities and trials on introduced products until successful development of the product before transfer to Technology Transfer team for full scale manufacturing • Check and review statutory requirements as mentioned in this SOP FD-01 prior to introduction of new product in Formulation • Oversee and co-ordinate with relevant sections for effective project planning, execution, project review to enable smooth operation of documentation and Formulation Development activities for new products • Prepare and review all necessary documentation including Formulation Development protocol and reports, annex for Critical Process parameters to be demonstrated, Master Batch Records, SOPs, Equipment qualification documents, Equipment equivalence documents, Change Requests, etc • Undertake and supervise the development and packing of the formulation batches as per the applicable SOPs and approve development process to ensure successful execution of Formulation Development • Manage the requisitions, inventory of spares, tooling, consumables related to Formulation Development through close collaboration with OEM, Engineering, and SCM Departments, with emphasis on cost management, and stock management through stock/inventory management to eliminate downtime • Prepare, review all QMS, Audits, Investigations, Corrective Action and Preventative Action (CAPA), effectiveness, compliance, reviews in regulatory requirements in relation to operations within the Formulation Development section that enable timely support and response to all CFT requirements • Manage performance through effective goal setting, periodic performance appraisals, engagements, skills enhancement, manpower planning and scheduling and training to maximize efficiency and optimize production processes

• Bachelor of Pharmacy Degree • At least 3 years’ experience in a pharmaceutical manufacturing setup • Experience in Research, Formulation and Process Development • Excellent communication, leadership and supervisory skills • Excellent organizational and time-management skills • Commitment to quality and continuous improvement • Ability to create clear, concise, and accurate documents/reports • Ability to work collaboratively with others • Understanding and adhering to relevant standards and regulations • Detail oriented and with excellent analytical • Self-started, flexible and able to work well under pressure • Computer knowledge (proficiency in MS office)