Quality Control Executive (Start ASAP)

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide. Syngene’s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by the passion of its 4240-strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation.

Your role

Key responsibilities of the role are:

• Initiation of QMS elements i.e. Change control, CAPA, deviation, Laboratory Incident, OOS, OOT, Non-Conformity as applicable. 
• Handling of  LMS, LIMS, ELN, TrackWise, and EDMS Software for routine activities as applicable. 
• Preparation of Specifications, Standard Operating Procedures, Instrument Operating Procedures, and General Procedures. Observation data sheets, calibration data sheets, protocols and reports, etc. 
• Review of Specification, Standard Operating Procedure, Instrument Operating Procedures, General procedures. Observation data sheets, calibration data sheets, protocols and reports, etc. 
• Reviewing LIMS/ELN relevant documentation, SOPs, training presentations, and any other documents related to CSV requirements for any enhancements or new implementation/Modules. Collaborating with IT and QA to facilitate validation activities, writing/execution/review of Test Scripts, and effective implementation of LIMS. Ensuring the proper functioning of LIMS application as per the business needs through rigorous testing.
• Creation/ preparation of documents, master data/ static data creation in LIMS, ELN, and LMS Software as applicable. 
• Review of documents and records related to routine operations in quality control. Review of documents in EDMS and TrackWise.
• Involve in the Investigation and closure of OOS, OOT, Laboratory incidences, deviation, and Non-Conformity as applicable.
• Check consignment documents like COA, MSDS, GRN, TRF, FTRF, etc, and monitor sampling of Raw materials,  Packing materials, In-process, Validation, Finished products, water sampling, and miscellaneous materials as applicable and certify the accuracy, adequacy, and timeliness of the activity performed by analysts. 
• Responsible for imparting training to New joiners, Consultants, Deputation Transfer, etc. 
• Record updation for Outsourcing of sample testing based on requirements and updating respective Logbooks.
• Archive and retrieve documents related to the section.
• Act as training coordinator for QC—assignment of procedural training and recording training in LMS  coordinating for internal and  External trainings etc.
• Adherence to Good Laboratory Practice and Good Documentation Practices.
• Cleaning of the workplace and following Good laboratory practices while working in the QC Laboratory.
• Individuals working in the GMP environment are responsible for documenting/recording the activities contemporaneously and accurately as per Good documentation practices. 
• Ensure safety compliance as per Syngene policy and EHSS requirements.
• Responsible for taking any other job allocated by Head QC / Group Leader /Section Head.

Training & development 

In Syngene, they believe Learning is a pre-requisite to Growth. They consistently reinforce the Culture of Learning by offering knowledge accessibility, as well as professional development through a blended learning approach designed to develop key skills, and knowledge capabilities and develop the right attitude.

All programs are custom-designed to suit the needs of the targeted population using techniques and kinds of training including on-the-job learning opportunities, classroom-based activities, webinars, experiential training, e-learning, and peer learning sessions. A variety of training and development workshops are run throughout the year as part of the training calendar for all employees including senior management.

Benefits

Besides the high-end technology infrastructure and advanced R&D facilities, Syngene has more to offer to its employees in terms of the support they receive in living a full life:

• Health Insurance
• World class cafeterias
• A well-designed and eco-friendly campus
• Child-care facility
• Round-the-clock transportation
• In-house ATM
• Annual health check facility
• Well-equipped gym to keep fit
• Job Training

Along with these, there are many other amenities provided by the company to ensure a safe and pleasant work environment.

Work-life balance

They encourage employees in Syngene to strike a balance between their careers and personal life. They provide a hybrid working option with flexible work timings. They manage a creative environment with a very good work-life balance. Work days are usually from Monday to Friday.

Culture & vibe

Building a unified culture around their values of integrity, excellence, and professionalism is an important part of the Syngene employee value proposition. 

Their staff are the key differentiator for their business. Their training, skills, experience, and commitment to every project ensure that they deliver high-quality research, development, and manufacturing services for their clients at all times. They strive to be a world-class employer to attract top talent and provide them with a stimulating and safe work environment and support in achieving their career ambitions.

About you

Educational qualifications

• M.Sc. / B. Pharma (Analytical/General Chemistry)/ B. Tech

Technical/functional skills

• Analytical experience in GMP Quality Control (APIs & oral solid dosage forms) with a reputed pharmaceutical company/CRO is an added advantage.
• Familiar with Chromatography and Non-Chromatography Analysis of Drug Substances and Drug Products.
• Familiar with SAP, Chromeleon, EDMS, LMS, and TrackWise application software.
• Basic knowledge of MS Word, Excel, PowerPoint, and Teams is mandatory
• Knowledge of 21 FR part 11 compliance requirements, ICH, and FDA guidelines.
• Awareness of Data Integrity policies/procedures, lab safety, and personnel safety
• Experience in the handling of QMS (laboratory incidents, deviations, OOS, and OOT).

Experience

• 0-3 years of relevant experience.

Behavioral skills

• Strong commitment towards work and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking-listening-writing skills, attention to detail, and proactive self-starter.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should be able to work in a team and flexible for working in shifts.
• Should be a focused employee.

How to apply

To apply for this role, just click on the "Apply on employers site" button, which navigates to the career section where the application can be submitted.

Sources

The following sources were used in researching the information for this page.

• Syngeneintl.com/careers/
• Ambitionbox.com/
• Youtube.com