Executive, Labeling Reviewer - Ahmedabad

Compilation and/or initial review of labeling documents for OSD & Injectable for original ANDA and Additional strength submission. · ...

DescriptionCompilation and/or initial review of labeling documents for OSD & Injectable for original ANDA and Additional strength submission. · Co-ordinate with CFT for involvement and understanding of priorities and filing timelines.  · Follow-up with respective department to ge ...

Description · JOB DESCRIPTION · This role ensures GMP and GxP compliance in dispensing, manufacturing, and packaging. Responsibilities include machine and area clearance, product sampling, in-process checks, batch record reviews, and raw material verification. The position also i ...

Preparation and Review of Standard Operating Procedures. · Review of BMR, BPR, ECR, PFD etc. · Responsible for Change Control Management. · Preparation and Review of Annual Product Quality Review. · Responsible for label management. · Responsible for Process Performance Qualifica ...

Design packaging concepts for products including boxes, labels, cartons, pouches and bottles. · Develop packaging layouts and mockups as per product specifications. · Collaborate with marketing product and production teams. · ...

Greetings from Synergy Resource Solutions ) a leading HR Consultancy Firm. · Our client company operates within the Industrial Intelligence sector, focusing on enhancing operational efficiency and safety in complex industrial environments. Their solutions bridge the gap between p ...

Greetings from Synergy Resource Solutions ) a leading HR Consultancy Firm. · Our client company operates within the Industrial Intelligence sector, focusing on enhancing operational efficiency and safety in complex industrial environments. Their solutions bridge the gap between p ...

+ Collaborate with cross-functional teams to develop and execute regulatory strategies for biological products. · + Prepare and submit regulatory documents, including CDSCO dossiers/queries, variations including scale-up changes, and annual reports. · Maintain compliance with app ...

Manage quality documentation and review executed batch records in manufacturing. · ...

The Regulatory Affairs Manager Europe will be responsible for compilation review and submission of eCTD dossiers renewal applications variations site transfer projects post marketing applications and any other relevant submissions for UK/EU/AU/NZ/CA regions. · ...

To compile and review product information for safety variation and non-safety variation affecting the product information, evaluate and review approved PI documents to keep approved PI documents in-line with reference product to comply regulatory requirements. · ...

The Senior Executive is responsible for preparation and review of standard operating procedures of packing department. · ...

Manage material receipt and storage for smooth operations and oversee ERP functions. Coordinate with departments for dispatch and handling of finished goods. · ...

Responsible for line clearance activity before commencing different operations like dispensing manufacturing filling inspection sealing labelling and packing. · Managing environmental conditions such as temperature humidity and light during stability testing to ensure accuracy co ...

The job involves preparing dossiers in CTD/ACTD/Country Specific Formats and handling queries related to registration requirements. · ResponsibilitiesDossier Preparation in CTD/ACTD/Country Specific Formats · Re-registration and Renewal Application · Variation Application · Que ...

Perform Quality review of bioanalytical data, including chromatograms, calibration curves and final reports. · ...

To perform accurate and reliable analysis of Raw material, · Finished Products, · In-process samples, · stability sample, · validation samples (process and cleaning validation), · Packaging material and water sample analysis as per method of analysis or protocol. · To perform acc ...

This is a QC apprentice role responsible for labeling, sampling and testing raw materials. The ideal candidate has a M.Sc in Chemistry or Organic Chemistry. · ...

This role involves reviewing batch records and log books, ensuring documentation is happening online and adhering to Quality Assurance (QA) activities. The ideal candidate will be responsible for issuing procedures to the manufacturing team and verifying adherence to Good Manufac ...

The Assistant Manager Regulatory Affairs is responsible for supporting regulatory submissions product registrations lifecycle management domestic international markets ensures compliance global regulatory requirements timely dossier preparation submissions effective response regu ...