Quality Control – Trainee To Junior Manager
Role & responsibilities
- Exp:0-5 Years | Qualification: B.Sc / M.Sc (Chemistry)
- Hands-on with HPLC, GC, UV, FTIR & wet chemistry techniques
- Ensure compliance with GMP, GLP, and maintain instrument calibration records
- Salary: 2.5-6 Lacs P.A.
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Regulatory Affairs Executive – Junior Manager
- Education UG: Any Graduate PG: Any Postgraduate
- Experience: 1 – 6 years
- Salary: 3-7 Lacs P.A.
- Location : Hyderabad
Role & responsibilities
- Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents according to EU regulatory requirements.
- To identify and classify the changes as per EU regulatory variation guidance.
- To prepare response to regulatory deficiencies letters according to EU regulatory requirements
- To collaborate with other departments/partners
- To maintain lists/documents/records
- Responsible for keeping Orion internal regulatory system up to date and accurate
- To achieve his/her responsibilities within the agreed timescales
- To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating
- Other possible tasks appointed by Supervisorsrs.
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DQA – Executive
- Education UG: Any Graduate PG: Any Postgraduate
- Experience: 1 – 6 years
- Salary: 3-7 Lacs P.A.
- Location : Hyderabad
Role & responsibilities
- Preparation of technology transfer documents like master formula record, scale up batch manufacturing record, batch manufacturing record, process validation protocol, hold time study protocol, batch packing record.
- Review of formulation development documents like tooling specification, trade dress for new product, pantone colour shade card, feasibility report, justification for specification, scientific study protocol and report and pharmaceutical development report.
- Preparation and review of Development Quality Assurance Standard operating procedures
- Review of standard operating procedures related to FD, Engineering and Stores.
- Review of stability study protocols & monthly balance verification.
- Number allocation for specification, method of analysis, laboratory standard testing procedure, analytical method validation protocol and report, analytical method transfer protocol and report, tooling specification, trade dress for new product, feasibility report, justification for specification, scientific study protocol and report.
- Secondary responsibility in ensuring, tracking the execution, assessment and completion details of QMS documents such as DCRF, CCF, incidents, OOS, OOT, deviation and CAPA.
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Project Management Executive / Senior Executive
Role & responsibilities
- Integrated Planning and Timeline Execution
- Maintain integrated cross-functional project plans and timelines for assigned programs in partnership with Global Program Manager and Senior Program Manager
- Partner with functional representatives to align project timelines with functional timelines and inputs
- Develop and maintain global filing and submission timelines with cross-functional partners, including Regulatory, and ensure plans are executed accordingly
- Facilitate and participate in global team meetings with cross-functional partners to confirm timelines and dependencies, identify risks, and develop mitigations
- Manage milestones, dependencies, and critical path items; assess downstream impacts of plan changes and support scenario planning
- Communicate key issues and risks to the Global Program Manager, Senior Program Manager, , and Line Manager, as appropriate
- Systems, Data Quality, and Reporting
- Maintain accurate, timely updates across planning and timeline tools, including Planisware, Microsoft Project, Smartsheet, and related tools
- Ensure data quality and cross-system consistency so dates and milestones are aligned and not conflicting across tools
- Conduct monthly quality checks of timeline and milestone data and correct issues quickly
- Develop project updates, dashboards, and visualizations based on approved plan information, using tools such as OnePager, Tableau, and other tools
- Collect and report project performance metrics to support planning and capacity management
- Follow established processes and data quality standards for planning and timeline systems, and flag gaps or improvement opportunities to the Senior Program Manager
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Production Trainee To Junior Manager
Role & responsibilities
- Perform day-to-day production activities in Compression, Coating, or Granulation areas as per Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs)
- Ensure compliance with cGMP and GDP guidelines across all manufacturing processes
- Coordinate with Quality Assurance, Quality Control, Engineering, and Warehouse departments for smooth operations.
- Monitor process parameters and critical control points, and ensure proper documentation of all activities.
- Manage and report any deviations, execute Corrective and Preventive Actions (CAPA) as required
- Train and guide machine operators, ensuring adherence to safety and hygiene standards in cleanroom environments
- Participate in internal and external audits, and maintain audit readiness at all times
- Support process improvements, cost-saving initiatives, and overall resource optimization
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