Job Location:
Hyderabad, Telangana, India.
Technical Qualification Senior Consultant
Requested Languages:
OR
Due to a constant growth, currently PQE Group is searching for a new Technical Qualification Senior Consultant, for our PQE India Consultants team.
- Development of qualification plans, user/technical requirements specifications, design qualification plans/protocols/reports, test plans, requirements-testing traceability matrixes, qualification summary reports
- Development of installation, operational and performance qualification protocols for equipment and utilities (e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized guidelines (e.g.: ASTM, ISPE, GAMP)
- Development of pharmaceutical processes flow charts, risk assessment and validation plans/protocols
- Development of cleaning validation strategies, risk assessment, plans and protocols
- Development of thermal validation study protocols
- Development of project validation master plans for new sites implementation including detailed Gantt charts with predecessors and resources workload evaluation (advanced knowledge of Microsoft Project requested)
- Development of risk-based technology transfer plans, protocols and summary reports
- Deep knowledge of ASTM E2500 standard for specifications, design and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment
Responsibilities may include, but are not limited to, the following:
Key technical skills:-
Nice to have technical skills:
- Knowledge of the main test instruments suites (e.g.: GE Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments)
- Coordination of junior resources for qualification testing execution and use of test instruments
- Development of risk based assessment at process, component and functional level according to the internationally recognized methodologies (e.g.: FMEA, HACCP)
- Development of calibration and maintenance plans and related instructions
- Development of standard operating procedures
- Advanced knowledge of EU and US GMP
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Other Skills
- Fluent English
- Technical Degree (Engineering, Chemistry, Pharmacy, Informatics, Physics)
- Minimum of 3+ years’ experience in the drug manufacturing area
- Availability to travel
- Integrity, strong analytical skills and attention to details
Full-Time Job
If interested, please send your resume in English clicking on the button on this page. Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.
