As one of the world’s most innovative consulting business transformation firm, we’re constantly on the lookout for brilliant minds like yours to help us deliver better results to our clients. Synthesis is built on an entrepreneurial DNA. Innovation, problem-solving and ingenuity are at the core of what we do. When you join Synthesis, you’ll discover it’s not just the work that’s diverse, its people and our culture too. You’ll be part of a team of extraordinary people from different backgrounds. Make no mistake, what we do here is hard and challenging work. Which is why how we work together is very important. Our culture makes daily challenges and tasks enjoyable and is one of the reasons why Synthesis is a great place to work.
We work with clients across the globe. What’s a better place for exposure and innovation.
We ensure your skill sets grows consistently by providing training, and learning opportunities.
From interns to experienced leaders, our people with diverse experiences help create a learning and fun environment.
We create and deploy disruptive and innovative solutions. Innovation is one of the key principles guiding us.
Syntheis Solutions is a connected enterprise, with open communication forming a cornerstone of our people policies.
We value the diversity of the markets in which we operate. Diversity, hence, is an integral part of our talent management strategies.
We support gender diversity and provide a work environment which nurtures talent. Some of our initiatives to promote diversity include maternity benefits, Etc.
At Synthesis Solutions, we have created a robust infrastructure to nurture and develop talent of our employees.
This job in brief:
1. Operate, troubleshoot, and maintain analytical equipment used in the laboratory, such as HPLC & GC.
2. Perform instrument preventive maintenance & Calibration as per the Master Schedule.
3. Perform HPLC & GC method validations according to protocols.
4. Maintenance of HPLC and GC columns and chemicals required for HPLC and GC analysis.
5. Perform day to day activities for the chemical laboratory which shall include testing of in-process, raw material, packaging material, finished product, stability samples and microbiological samples.
6. Prepare controlled documentation in support of the sampling, analysis, and reporting of results.
7. Preparation of working standards, maintaining of reference standards and impurities management as per approved SOP
8. Following policies, protocols, and Standard Operating Procedures (SOPs).
9. Compliance with, GMP, ISO, HACCP guidelines, FDA & other local /International regulatory bodies
This job in brief:
1. Develop standard operating procedures (SOPs) and analytical methods for various quality control aspects of the finished products and intermediates like content uniformity, blend uniformity, particle size analysis using Malvern Instrument.
2. Performing analysis for the characterization of drug substances and release of raw materials (RM) and packaging components
This job in brief:
1. Design, Author, and Execute Computerized System Validation (CSV) – according to GAMP 5 guidance – especially on Analytical Laboratory Test Equipment and other Lab Information Systems.
2. Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents
3. Perform and support compliance / validation activities.
4. Understand and adhere to the Client Regulations/Processes of Computerized System Validation concept with regards to document management, and V Model Methodology
5. Assessing the Functional Risk & Mitigation & preparation of Impact assessment validation documents with respect to application & Equipments.
6. Good knowledge of GMPs, 21CFR Part 11, USP 1058 – and other relevant industry regulations and guidance
7. Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
8. Translate technical information and requirements into qualification/validation test design.
9. Strong interpersonal skills and demonstrated ability work independently.