Syngene Chemistry Senior Executive Vacancy – Apply Online

Syngene Chemistry Senior Executive Vacancy – Apply Online

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Job Title: Senior Executive

Job Location: Mangalore

Department: Quality Assurance

Educational Qualification: M.Sc Chemistry

Technical/Functional Skills:

• Good working knowledge of ICH Guidelines, Schedule M of Drugs and Cosmetics Act of India, 21 CFR, EU & MHRA GMP regulations
• Good working knowledge in MS Office (Word, Excel, Powerpoint)
• Fair Knowledge of statistical tools like Minitab, Statistica
• Must have good communication skills – Oral and Written
• Good report writing skills

Experience:

3-5 years of experience in API Manufacturing plant

Behavioral Skills:

• Should be highly quality conscious with an urge to protect product quality and patient safety
• Must have keen sense of observation
• Good common sense ability
• Must be a team player and have good interpersonal relationship skills

Job Purpose 

Efficiently review the documents pertinent to batch release and ensure compliance to laid down procedures.

Key Responsibilities: 

• Review of executed batch manufacturing records, batch packing records, batch cleaning records.
• Review and ensure closure of QMS records related to the batch and were open, with due justification, before releasing of the batch.
• Review of audit trail records of the GMP computerized systems as part of the batch release.
• Ensure online trending of critical process parameters, critical in-process controls, critical quality attributes and report the deviations to the normal operating ranges.
• Ensure the quality management system documents are appropriately addressed prior to release the batch.
• Responsible to verify the weights of the dispatched material as per the batch packing record.
• Verify the customer agreements for compliance and ensure the agreements are followed all the time.
• Responsible to follow the Good documentation practices, Data integrity principles, company policies and regulations.
• Ensure collection of requisite quantity of retention samples
• Release of the batch in accordance to laid down procedure.
• Review of specifications, manufacturing, packing, quality control records pertinent to the batch
• Review of quality agreement pertinent to the client for whom the batch/es are manufactured.
• Review of QMS documents (change control, deviation, OOS, LIR, Investigations reports, CAPA etc.) related to the batch.
• Ensure closure of the QMS documents, as applicable before release of the batch
• Ensure online trending of critical process parameters and critical quality attributes related to the product.
• Ensure collection of requisite quantity of retention samples
• Release of the batch in accordance to laid down procedure.
• Evaluate and clear the line for Manufacturing, Packing, Quality Control testing as per approved procedures
• Ensure assurance on the execution of manufacturing, packing, quality control testing, and Engineering & Maintenance processes as per laid down procedures
• Ensure assurance of online documentation of activities
• Ensure assurance of investigation of root cause and implementation of CAPA in the event of failures / observed non-compliances during internal and external audits
• Evaluate the effectiveness of implemented CAPA.

Apply Online

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