job location Job Location:

Hyderabad, Telangana, India.

 

Technical Qualification Senior Consultant

Requested Languages:

English
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job at pqe

Due to a constant growth, currently PQE Group is searching for a new Technical Qualification Senior Consultant, for our PQE India Consultants team.



    Responsibilities may include, but are not limited to, the following:
    Key technical skills:
  • 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
    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
    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.


job at pqe