Qc Associate
7 months ago
Analysis of the campaigns, investigations, and related analyses with trouble shooting
- Execution of the Analytical method validation as per the protocol
- Preparations of equivalency reports, transfer protocols & reports, investigation protocols & reports etc.
- Maintenance of lab compliance such as calibration schedules etc, preparation of SOPs and other documents.
- Coordination with CFTs e.g QC for analysis requirements, QA for document authorization and RA for filing requirements.
- Evaluate and use orthogonal approaches to resolve a problem and investigate the cause.
- Designing, Planning and execution of analytical activities
- Review analytical data generated on different analytical techniques for completeness and adequacy
- Analysis of results and discussion with the formulation team during the product development until the filing.
- Interaction with RA for filing requirements. Providing required data to regulatory and quality of respective plants in support of executing the project at plant and filing.
- Coordination with SCM & FR&D planning for analysis. Analyzing the results, documenting the observations and results and preparing the report.
- Respond to regulatory deficiencies on time.
- Identify the training needs of the team & implement effective training calendar for all the team members.
- Actively participate and resolve OOT/OOS observed at plants during stability analysis.
- Good data analytical skills with creative thinking ability.
- Guide the team in designing experiments on appropriate analytical techniques which are suitable and adequate for product development
-
HCLTech | Associate Director | hyderabad
2 weeks ago
hyderabad, India HCLTech Full timeLooking for a candidate at the level of an ‘Associate Director’ that can drive innovation and excellence in lab systems implementation within pharmaceutical sector Lead and provide strategic direction to a global team accountable for delivering (Opex & Capex), and lifecycle of laboratory information management systems, QC Lab enterprise systems,...
-
Associate Director
2 weeks ago
Greater Hyderabad Area, India HCLTech Full timeLooking for a candidate at the level of an ‘Associate Director’ that can drive innovation and excellence in lab systems implementation within pharmaceutical sector Lead and provide strategic direction to a global team accountable for delivering (Opex & Capex), and lifecycle of laboratory information management systems, QC Lab enterprise systems,...
-
Associate Director
2 weeks ago
Greater Hyderabad Area, India HCLTech Full timeLooking for a candidate at the level of an ‘Associate Director’ that can drive innovation and excellence in lab systems implementation within pharmaceutical sectorLead and provide strategic direction to a global team accountable for delivering (Opex & Capex), and lifecycle of laboratory information management systems, QC Lab enterprise systems,...
-
Creative Studio Associate
6 months ago
Hyderabad, Telangana, India Aeries Technology Full timeJob Id: Aeries/029/24-25 Industry IT-Software / Software Services / testing Location Hyderabad Experience Range 5 - 9 Years Qualification Graduation **Job Description*** **About Us** **About Business Unit** A privately held Azurity Pharmaceuticals company held products that meet the needs of patients with underserved conditions by providing unique,...
-
QC Team Lead
7 months ago
Hyderabad, India Delta Capita Full timeDescriptionPosition : QC KYC Team LeadLocation : Hyderabad, IndiaReports to VP CLMEmployment Type: PermanentMode: 5 days work from officeWorking Hours: UK Business HoursThe RoleWe are looking for a KYC Quality Controller (QC)/Subject Matter Expert (SME) Team Lead to join our Client Lifecycle Management (CLM) Managed Service Business. You will be responsible...
-
Tmf Compliance Associate
6 months ago
Hyderabad, Telangana, India Novartis Full time392251BR **TMF Compliance Associate**: India **About the role** Your responsibilities include, but are not limited to: - Support QC/completeness checks on all global TCO study TMFs in accordance with Novartis SOPs, working practices and ICH/GCP Guidelines. Follow-up with the CTT to resolve quality issues identified and escalate potential SOP/WP...
-
Clinical Project Associate
6 months ago
Hyderabad, Telangana, India Novartis Full time**Summary**: - Support QC/completeness checks on all global TCO study TMFs in accordance with Novartis SOPs, working practices and ICH/GCP Guidelines. Follow-up with the CTT to resolve quality issues identified and escalate potential SOP/WP deviations.. - Maintain up to date knowledge of the TMF Reference Model. Support documentation of appropriate...
-
Associate, Regulatory Affairs
1 month ago
Hyderabad, India SteriMax Inc. Full timePosition Title:Associate, Regulatory AffairsReports To:Director, Regulatory AffairsLocation:Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...
-
Qc Associate
6 months ago
Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time**Company Description** Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because **Good Health Can’t Wait**. We started in 1984 with a modest...
-
Aqa Associate
6 months ago
Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full timeMentioned skills needed for the Open position: - Analytical Techniques understanding (HPLC, ELISA, TOC, Glycan etc.). Hands on experiences is preferred in the mentioned techniques as part of QC or R&D. - Analytical QA experience for at least 3 years. - Experience in facing FDA/EMEA/EU audit and Drafting Regulatory Queries response. - Review skills of BAR...
-
Associate, Regulatory Affairs
2 weeks ago
Hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...
-
Associate, Regulatory Affairs
1 month ago
hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...
-
Associate, regulatory affairs
1 month ago
Hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...
-
Associate, Regulatory Affairs
1 month ago
hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...
-
Quality Control Executive
6 months ago
Hyderabad, India Sunlite Food Products Full timeWe require a QC Executive for a food manufacturing company with past experience in the food and beverage industry, working and implementation knowledge of ISO/FSSC 22000 and associated auditing certification, along with experience in documentation, GMP implementation and quality assurance. **Salary**: ₹22,000.00 - ₹25,000.00 per month Ability to...
-
Associate, regulatory affairs
1 month ago
Hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...
-
Associate, Regulatory Affairs
1 month ago
hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, India POSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. KEY...
-
Associate, Regulatory Affairs
1 month ago
Hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, India POSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. KEY...
-
Associate, Regulatory Affairs
1 month ago
Hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...
-
Associate, Regulatory Affairs
1 month ago
hyderabad, India SteriMax Inc. Full timePosition Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...