05 Oct
|
MSN Group
|
Hyderabad
05 Oct
MSN Group
Hyderabad
Role & responsibilities
TSD Formulation | Executive / Senior Executive
– TSD (Formulation)
Company: MSN Laboratories
Department: Technical Services & Development (TSD) – Formulation
Designation: Executive / Senior Executive
Experience: 2–6 Years
Location: Hyderabad, Telangana
Job Purpose To provide technical support for formulation manufacturing, scale-up, technology transfer, process optimization, troubleshooting, and commercialization of pharmaceutical products while ensuring compliance with GMP, quality, safety, and regulatory requirements.
Key Responsibilities
- Provide technical support to manufacturing operations for formulation products.
- Support technology transfer activities from Formulation R&D; / Development to commercial manufacturing sites.
- Review formulation development reports, manufacturing processes, batch records, specifications, and process parameters.
- Coordinate and execute scale-up, exhibit, engineering, process validation, and commercial batches.
- Monitor and evaluate manufacturing process parameters and product quality attributes.
- Identify process-related issues during manufacturing and support effective troubleshooting.
- Conduct root-cause analysis for process deviations, failures, and recurring manufacturing issues.
- Support preparation and review of deviation investigations, CAPA, change controls, and technical assessments.
- Evaluate process trends and manufacturing data to identify opportunities for process optimization and improvement.
- Support process optimization, yield improvement, cycle-time reduction, and reduction of manufacturing variability.
- Review and prepare technical documents such as technology transfer protocols/reports, process evaluation reports, technical investigations, and risk assessments.
- Coordinate with Formulation R&D;, Production, QA, QC, Engineering, Regulatory Affairs, and other cross-functional teams.
- Participate in manufacturing trials and provide on-floor technical support during critical batches.
- Support development and implementation of process controls and manufacturing strategies.
- Ensure appropriate identification and evaluation of CPPs, CQAs, and critical material attributes (CMAs).
- Support Process Validation and Continued Process Verification (CPV) activities.
- Review batch manufacturing records and provide technical inputs for process improvements.
- Support investigation of OOS/OOT and other product/process-related quality events from a technical perspective.
- Assist in preparation of responses to regulatory queries related to formulation manufacturing and process development.
- Ensure activities are performed in accordance with cGMP, SOPs, safety requirements, and applicable regulatory guidelines.
- Maintain effective documentation and ensure timely completion of assigned TSD projects.
Technical Skills / Knowledge
- Strong knowledge of pharmaceutical formulation manufacturing processes.
- Experience with Oral Solid Dosage (OSD) products such as tablets and capsules.
- Working knowledge of
- Dispensing and sifting
- Dry/wet granulation
- Blending
- Compression
- Film coating
- Encapsulation
- In-process controls
- Understanding of scale-up and technology transfer principles.
- Knowledge of CPP, CQA, CMA, QbD, and Quality Risk Management.
- Knowledge of process validation and continued process verification.
- Understanding of deviation, change control, CAPA, OOS/OOT, and investigation processes.
- Familiarity with GMP and regulatory requirements.
- Ability to interpret manufacturing and process data for troubleshooting and optimization.
Qualification
- M.Pharm / M.S. (Pharmaceutics/Pharmaceutical Technology) preferred.
- B.Pharm candidates with relevant TSD/Formulation experience may also be considered.
Experience Executive – 2–4 Years
- Relevant experience in Formulation TSD, Formulation R&D;, Technology Transfer, Scale-up, or Pharmaceutical Manufacturing.
- Hands-on exposure to manufacturing troubleshooting and technical documentation.
- Experience supporting formulation manufacturing batches is preferred.
Senior Executive – 4–6 Years
- Relevant experience in Formulation TSD / Technical Services / Technology Transfer / Scale-up.
- Demonstrated experience in troubleshooting formulation manufacturing processes.
- Experience in process optimization, validation batches, technical investigations, and cross-functional project execution.
- Experience in regulated pharmaceutical manufacturing environments preferred.
Key Competencies
- Technical problem-solving and troubleshooting
- Analytical thinking and data interpretation
- Solid knowledge of formulation manufacturing
- Cross-functional coordination
- Technical report writing and documentation
- Good communication and interpersonal skills
- GMP and compliance awareness
- Ability to work independently and manage multiple technical activities
- Strong on-floor manufacturing support capability
Key Performance Areas
- Successful technology transfer and scale-up
- Timely resolution of manufacturing technical issues
- Process optimization and yield improvement
- Successful execution of validation/commercial batches
- Effective deviation and investigation support
- Timely completion of technical documentation
- Compliance with GMP and internal quality systems
📌 Executive / Sr Executive -TSD Formulations (Hyderabad)
🏢 MSN Group
📍 Hyderabad