Pregna International Ltd.

Daman, Daman & Diu

Job descriptionKey Responsibilities of Candidate:1. Approve or reject, inputs, intermediate products, and finished products2. Ensure that all tests and determinations established are performed3. Ensure the evaluation of dossiers of manufacture of each product batch before release4. Approve specifications, sampling instructions, test methods, and analytical determinations5. Ensure that the analysis carried out by contract is reliable6. Reviewing completed batch production and laboratory control record of critical process steps before releasing of Batch7. Ensure that critical deviations are investigated and resolved8. Ensure validation of analytical methods are conducted, studies of the suitability of pharmacopeia methods, equipment qualification, and calibration of analytical instruments9. Review and Approve Validation protocols and reports10. Ensure that quality-related complaints are investigated and resolved11. To perform product quality review12. To review and approve Quality Manual13. To represent and lead the team during audits14. Conduct job-related training for subordinates and ensure the documentation & job description. To contribute in meeting the quality standards by ensuring that all tests and analyses of samples are carried out in time to meet the laid down specifications and meet the customers requirement. cGMP and regulatory requirements are fully implemented15. To review & approve all specs, test methods, SOPs, MFR, BMR, SMF, etc16. To make sure that critical deviation, change control & customer complaint are investigated, addressed, and closed accordingly with necessary corrective & preventive action17. Conduct Vendor Audit18. To prepare compliance reports for external audits in coordination with different departments19. To review and approve the qualification protocols and reports (DQ, IQ, OQ, and PQ)20. To inform customers /Regulatory agencies in case of any major process change21. Establish and maintain the policy for the do

Job PurposeTo develop and implement marketing strategies and to drive the business objectives and maximize profitability.Responsibilities Implement marketing strategies, assess growth opportunities for Pregna products to maximize profitability. Service the existing customers & develop relationships with Key Opinion Leaders, and other stakeholders to ensure growth of portfolio. Conduct market research for potential business opportunities. Plan to research and launch new products wherever appropriate. Long range forecasting in present and future indicationsExperience in Marketing with these required skills to achieve our goals: Considerable knowledge of marketing products or services Strong communication (written and oral) skills Forecasting accuracy Interpretation and communication of market dynamics and brand strategy to senior management Ensure co-operation between marketing, and other departments to ensure effective strategy implementation Collation of market and brand specific data from diverse data sources Develop insight and understanding of the customer and the market Show initiative and creativity in the development of the brand strategy

We actually need a Automation Engineer having experience in PLC and Automation, and also experienced in solid works or solid edge. Minimum Experience required is 5 to 6 years and Qualification : B.E. Electronics / Electrical / Instrumentation.Background:New Product Development, Medical Device Manufacturing, ISO 13485, ISO 14791, Jigs & fixture Development, SPM Development, Automation. Design History file.JD:1. Delivery of features1.1 By planning the feature development1.2 By working closely with the engineering team to align them with the requirements1.3 By tracking the development progress2. Good quality of the product2.1 By developing the verification and validation plans2.2 By working with the quality team to execute on the verification and validation suite3. Adherence to 13485 and 62304 standards.3.1 By understanding the requirements of these processes through reading and training.3.2 By ensuring all the correct development processes are being followed3.3 By creating the documentation required4. Cost Effective Solution4.1 By learning the new technologies4.2 By Implementing in house solution5. Documentation5.1 By making Design history file5.2 By updating SOP, Process Flow5.3 By Making technical documentsQualification:Mechatronics Engg/ Instrumentation