Leverage resources to optimize production output whilst focusing on maintaining quality and safety standards

Oversees the daily activities of the plant operations. Develops and manages production schedules to meet internal volume, cost, and quality goals. Analyzes production metrics and makes recommendations for improvements and solutions to issues that are identified

• Bachelor Degree in Mechanical or Chemical Engineering preferred
• 5 to 10 years’ experience as a Plant Manager
• Good understanding of regulatory requirements for operating pharmaceutical manufacturing plants
• Adequate knowledge of business and management principles
• Familiarity with industry standard equipment and technical expertise
• Be knowledgeable of safety, quality, productivity, demand creation, inventory and stewardship processes

In a saturated market, innovative, more effective and affordable products are what provides not only the competitive edge but also saves human lives

• Formulate new products, from development to commercialization, within defined company, industry, and regulatory parameters
• Handle Technology transfer related activities.
• Establish guidelines and criteria for acceptance and testing of chemical raw-materials in finished blends
• Evaluate raw materials and packaging materials
• Evaluate & develop new technologies related to pharmaceutical processing
• Change existing formulations to reduce product cost

• Develop specifications for new and/or reformulated products
• Create Project Timelines in accordance with Marketing priorities, set milestones/critical path and ensure on time project completion.
• Operate within company’s Quality Management System
• Participate in team driven activities to facilitate on- going production improvements or new product development projects.
• Communicate effectively and consistently in writing and verbally with all levels of staff
• Collaborate in cross functional teams
• Consistently enforce all company policies & procedures.

• Test formulations using assays
• Conduct stability studies on formulations
• Perform scale up for transition to manufacturing
• Write necessary documents for manufacturing feasibility
• Evaluate technologies brought from third parties.
• Prepare product registration documentation and product chemistry packages to meet regulatory requirements.
• Responsible for batch production from pilot scale to process validation.
• Perform additional special projects as assigned.

• Masters degree or PhD in Chemistry
• 5-7 years technical experience in chemical or pharmaceutical manufacturing
• Experience with HPLC testing and other stability testing methods.
• Proven problem solving skills and track record of successful technical accomplishments
• Strong understanding of cGMP guidelines and regulations related to the pharmaceutical industry
• Proficient using MS Office applications.
• Experience with regulatory agency requirements

 The success of pharmaceuticals depends upon the Quality of the drug, Quality is paramount in an industry where human life at a stake

Design, implement, and improve company quality standards. Analyze data in order to find areas for growth. Assist in the recruiting process. Training, motivating, coaching, and correcting employees to ensure that standards are met.

• Bachelor degree in appropriate discipline with Chemistry as a core subject
• Experience with QA measuring and testing equipment
• 5 to 10 years’ experience in a similar capacity
• Knowledge of safety requirements and legal standards
• Familiar with Pharmaceutical Quality Management systems

Responsible for managing business development in the PD division by planning, reporting, budget setting and management whilst responsible for sales process optimization, sale program implementation and regulatory
compliances.

• Ensure to achieve departmental revenue and profits targets in a consistent manner to support the organizational financial objectives.
• Responsible for efficient cash flow management by managing receivables, payables, and inventory.
• Responsible for maintaining positive sustainable customer relationship through high degree of customer satisfaction by providing product related support consistently.
• Responsible for attracting new customers and retention of existing customers by building up a strong business rapport and minimizing customer churn to create and sustain a competitive edge in the market.
• Ensure to maintain positive business relationship with key opinion leaders in
• respective business segments in government and private institutions to understand customer challenges and needs.
• proactively monitors and maintain high level of quality and accuracy in ordering, regulatory compliance, investment appraisal through effective planning and timely co-ordination on the activities with other stakeholders of the organization.
• Identify training needs based on areas of improvement and co-ordinate with HR on a business priority

• Ensure to conduct knowledge transfer sessions with the team.
• Work closely with management. Review process quality and prioritized opportunities for improvements.
• Conduct periodic review on performance and efficiency based on set goals.
• Lead the sales team to a learning culture and support the organization change initiatives.
• Build peer support and strong company relationship with other mangers and staff by participating and supporting company activities.
• Obtain NMRA and Customs Clearance approvals and proceedings.
• Business development and related areas.
• Agency related discussions with related to business and market development

• Bsc Degree or Diploma in CIM or SLIM. MBA is an added advantage
• 3-4 years work experience in a similar capacity
• 6-8 years overall work experience in the healthcare industry.
• Interpersonal and communication skills.
• Demonstrable leadership skills.
•  Teamwork

Our Client is  the  largest pharmaceutical companies in Sri Lanka with the representation of many international pharmaceutical brands. With the ongoing expansion in our business, we are looking for talented young individual to join our team as Executive – Regulatory.

• Responsible in checking the labels, PIL inserts, stability reports, validation reports and COAs (Clinical Outcome Assessment) generated by internal departments.
•  Ability in preparation of technical documents. (e.g., Product Information Leaflets (PIL) by using
  the relevant references.)
•  Ability to closely work with key decision makers in the government bodies to expedite the registration process.
• Organize, update, and maintain regulatory documentation in accordance with department and company procedures.

• Candidate should possess B.Sc. Special in Pharmacy/ B. Pharma Degree/Sciencedegree orrelated professional qualification from a recognized University or an Institution.
• Minimum 02 years working experience in executing regulatory processes in Medical Devices/Pharmaceutical industry.
• Strong analytical, negotiation and people management skills to work along with multiple stakeholders across the business with strong learning agility.
• Proficient in MS office packages and IT literacy.