Team member - MSAT
Team member - MSAT
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
We are seeking a detailoriented and collaborative Team Member for our Manufacturing Science and Technology (MSAT) department in Pydibimavaram India. This role is crucial in ensuring smooth execution of various batches from confirmatory to validation and supporting process optimization and scaleup activities.
- Execute and monitor confirmatory trial scaleup exhibit prevalidation validation and placebo batches
- Demonstrate successful process scaleup for timely execution of confirmatory exhibit prevalidation and validation batches
- Prepare and review essential documents such as Master Formulation Records (MFR) Process Instructions Sheets (PIS) sampling plans and master production records
- Perform scaleup correlations for all unit operations from lab to plant scale
- Analyze data and provide support in addressing processrelated regulatory deficiencies
- Prepare and review protocols and reports for hold time studies submission batches Process Performance Qualification (PPQ) and stability studies
- Coordinate with crossfunctional teams to ensure timely completion of activities
- Conduct investigations prepare detailed reports and recommend appropriate corrective and preventive actions (CAPA) for submission and validation batches
- Plan and execute trials to identify probable root causes of issues
- Initiate change control procedures as required for batch execution
- Support cleaning verification and validation activities
Qualifications :
- Masters degree in Pharmacy
- 37 years of experience in Process Development Technology Transfer or MSAT
- Proven expertise in process development scaleup and technology transfer of solid dosage forms
- Strong understanding of pharmaceutical process selection and optimization
- Proficiency in preparing technical protocols and reports
- Experience with process engineering and risk assessment approaches
- Indepth knowledge of ICH guidelines and other relevant regulatory requirements
- Familiarity with statistical software and data analysis techniques
- Solid background in analytical research and data interpretation
- Excellent communication and interpersonal skills
- Strong analytical and problemsolving abilities
- Performanceoriented mindset with a focus on continuous improvement
- Ability to work collaboratively within a team and across functions
- Commitment to learning and coaching team members
- Familiarity with Good Manufacturing Practices (GMP)
- Knowledge of regulatory requirements in pharmaceutical manufacturing
- Willingness to work in Pydibimavaram India
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
