• Responsible for assurance human resource objectives by recruiting, training, monitoring, and reviewing job contributions. Being responsible for quality control team. • Achieves quality control operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.• Develops quality control plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures• Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.• Performing internal and external quality audits.• Good knowledge of Quality System regulations, such as GMP and ISO 13485• Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.

• Supervising the day-to-day activities in the laboratory• Establishing lab procedures, creating and managing lab-related documentation and organizes laboratory activities• Representing a laboratory for scientific conferences and workshops • Evaluating and hiring job applicants, and organizing training and laboratory orientation• Supervising lab work to ensuring timely completion of service requests

• Development and validation of new analytical methods • Independent planning and implementation of research processes related to the operation of the laboratory • Perform maintenance and troubleshooting of lab equipment• Write and maintain SOPs relating to the group’s activities (Analytical method, equipment use and maintains etc.)• Provide training and supervise junior staff in routine activities • Participation in the implementation and maintenance of quality systems ISO / IEC 17025 : 2005 and GLP laboratories• Remain abreast of new technological developments as they relate to the analytical methodology and propose method improvement

• Design, develop, validate and apply analytical methods for testing APIs, intermediates, reference standards and raw materials and in support of process development activities• Assist in the production of quantities of API to support pre-clinical and clinical activities by performing testing to ensure the appropriate quality is delivered• Participate in method transfer to the other departments• Write and maintain SOPs relating to the group’s activities (Analytical method, equipment use and maintains etc.)• Generate the necessary data and reports to support clinical trial application submissions for peptide APIs. Record all work and maintain documentation to the required standard• Remain abreast of new technological developments as they relate to the analytical methodology and propose method improvement

• Provide analytical support to process optimisation and troubleshooting activities for commercial products and projects. • Provide analytical support for unplanned events arising in manufacturing and quality, using the range of analytical technologies.• Provide analytical support to Industrial Development Chemists in process change or process optimisation. • Develop and validate of new and existing analytical methods for raw materials, intermediates, in-process testing and APIs.• Purchase of new laboratory equipment. • Train personnel with analytical methods, equipment use and maintains. • Review analytical documentation.

• Perform the analysis of: raw materials, in-process intermediate samples, API’s, stability samples and cleaning samples in a timely manner according to approved analytical SOPs and as per relevant specification.• Complete results in a timely manner with attention to the detail of the SOP and documentation. • Perform routine instruments calibration and calibration check. • Create and maintain of up-to-date laboratory Standard Operating Procedures (SOPs) and test procedures• Performed Installation and Operational Qualification of laboratory equipment.

• Perform chemical analysis of finished product samples adhering to Good Laboratory Practice (GLP) standards and the European Pharmacopeias.• Complete documentation associated with analytical results in a timely manner.• Undertake comprehensive stock checks and order replenishments of chemicals and equipment as required.• Monitor the environment within manufacturing areas including particle count, temperature, humidity and bacterial check.• Perform external audit in contract companies to verify whether activities comply with current Good Manufacturing Practices (cGMP) requirements, company standards and other applicable regulations.• Sample and test primary packaging materials to ensure adherence to industry standards and Health and Safety requirements.• Collect and inspect finish product retain samples with regulatory and site standards. • Generate certificate of analysis of finished products and trend data .