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QC Analyst

2 months ago

Bengaluru, India Syngene Full time

JOB DESCRIPTION

Designation:  Sr. Executive

Job Location:  Bangalore

Department:  Quality Control – Small Molecule

  AboutSyngene
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 around the world. 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.


Job Purpose:
QC Analyst

Job Description:

Ensure compliance with GMP, GDP, and GLP procedures and identify the cause of non-compliance. Ensure compliance with Data integrity policy and identify the cause of non-compliance. Ensure compliance with the safety policy. procedures, and stated requirements and identify the cause of non-compliance. Ensure compliance with SOPs and approved instructions and identify the cause of non-compliance. Ensure the training and qualification of analysts working in the respective area of QC laboratory. Preparation and revision of SOPs, IOP, EOP, protocols, schedules, and other related documents as applicable. Ensure the issuance and archival of logbooks, forms, and formats within SLA as per procedure Implement improvement ideas and appropriate measures to reduce Nonconformance and increase productivity. Provide appropriate and timely responses to audit observations. Provide timely compliance to the audit observation and track the proposed CAPA Perform self-inspection and ensure manufacturing operations are maintained in an all-time audit-ready (ATAR). Ensure the identified gaps have adequate control measures and appropriate actions have been taken. Ensure all the instruments are Qualified and calibrated as per schedule and requirements. Review of Quality agreement as applicable. Maintain the list of Quality agreements. Review of Client Questionnaire and ensure the confidentiality of document'/ Review of investigation, Categorize the Deviation and provide inputs in the identification of root cause. Review change control. Approval of extension if change control unable to close within the specified timeline. Initiation of investigation, risk assessment and provide inputs in the identification of root cause and to propose the CAPA for identified CAPA. To perform analysis by different analytical techniques like HPLC/GC/UV/IR/KF etc. Have hands on experience on analysis thru LIMS. Investigation, provide inputs in the identification of root cause and to propose CAPA. To initiate change controls and CAPA in a timely manner. Ensure preparation and review of specification within SLA and ensure compliance. Perform pharmacopeial/Regulatory Assessment /surveillance on introduction / revision of new / revised monograph and general chapters/guidelines Ensure the execution of process validation and cleaning validation activities. Ensure CSV-related documents and ensure compliance from the concerned person/section. Ensure the archival of documents and third-party archival activity within SLA and ensure the compliance from the respective department. 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. Handling of LMS, LIMS, ELN, TrackWise and EDMS Softwares for routine activities as applicable. Ensure the availability of optimum resources and operate the department within the specified budget. Support the Department Head in preparing the annual budget. Communicate promptly and effectively with the clients and CFT members. Ensure training completion before the startup of assigned activities. Responsible for taking any other job allocated by the Head QC / Group Leader /Section Head.

Key Responsibilities:
1. Ensure compliance with GMP, GDP, and GLP procedures and identify the cause of non-compliance.

2. Ensure compliance with Data integrity policy and identify the cause of non-compliance.

3. Ensure compliance with SOPs and approved instructions and identify the cause of non-compliance

4. Ensure review of Executed BMR within SLA and ensure compliance from the respective department.

5. Provide appropriate and timely responses to audit observations.

6. Perform self-inspection and ensure manufacturing operations are maintained in an all- time audit-ready (ATAR).

7. Ensure the archival of the document and third-party archival activity within SLA and ensure compliance from the respective department.

8. Overall adherence to safe practices and procedures of oneself and the teams aligned

Educational Qualification:   M.Sc.

Technical/functional Skills:
• Good communication skills, computer literacy and experience in API/formulation industry.

Experience:  3—6 Years


Behavioural 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 details, 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 team and flexible for working in shifts.

• Should be a focused employee.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.