Checking job availability...
Original
Simplified
- Provides support in manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site.
- Provides technical expertise related to manufacturing process and equipment in response to deviations and design of experiment to understand and eliminate the root cause(s).
- Support investigations from chemistry/process perspective for product complaints and deviations.
- Identify and develop necessary laboratory experiment for continuous improvement projects. Work closely with process engineers and other departments to deliver these continuous improvement projects including change control management.
- Participate in PHA and quality risk assessment activities providing relevant technical knowledge related to process chemistry and safety.
- Actively participate to collaboration and learning of best practices with external subject matter experts (SMEs) including GPRD, MS&T on process development for suitable future product introduction.
- Provides support to regulatory filings and cGMP audit activities.
- Authors technical reports, batch records, SOP’s, investigations, protocols as required and ensures consistency and quality of the group’s documentation in compliance with company guidelines.
- Any other duties as assigned by supervisor.
- Bachelors/Masters/PhDs degree In a technical/science field, including Chemistry, Biochemistry or Pharmaceutical Sciences.
- 0-6+ years (bachelor)/0-4+years (Master)/0-2+ year (PhD) technical experience in process chemistry, pharmaceutical manufacturing process, tech transfer, commissioning and validation in pharmaceutical industry.
- Knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is preferred.
- Demonstrated process development skills, including the ability to deliver innovative process chemistry at scale.
- Proven records in facilitating the successful transition from laboratory to full scale production.
- Experience of start-ups and new product introduction to commercial facilities is preferred.
- Good problem solving skills, embrace problem solving tools like FMEA, 5 Why, able to work under pressure and tight timeline.
- Team player, highly self-motivated and able to work under minimum supervision.
- Provides support in manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site.
- Provides technical expertise related to manufacturing process and equipment in response to deviations and design of experiment to understand and eliminate the root cause(s).
- Support investigations from chemistry/process perspective for product complaints and deviations.
- Identify and develop necessary laboratory experiment for continuous improvement projects. Work closely with process engineers and other departments to deliver these continuous improvement projects including change control management.
- Participate in PHA and quality risk assessment activities providing relevant technical knowledge related to process chemistry and safety.
- Actively participate to collaboration and learning of best practices with external subject matter experts (SMEs) including GPRD, MS&T on process development for suitable future product introduction.
- Provides support to regulatory filings and cGMP audit activities.
- Authors technical reports, batch records, SOP’s, investigations, protocols as required and ensures consistency and quality of the group’s documentation in compliance with company guidelines.
- Any other duties as assigned by supervisor.
- Bachelors/Masters/PhDs degree In a technical/science field, including Chemistry, Biochemistry or Pharmaceutical Sciences.
- 0-6+ years (bachelor)/0-4+years (Master)/0-2+ year (PhD) technical experience in process chemistry, pharmaceutical manufacturing process, tech transfer, commissioning and validation in pharmaceutical industry.
- Knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is preferred.
- Demonstrated process development skills, including the ability to deliver innovative process chemistry at scale.
- Proven records in facilitating the successful transition from laboratory to full scale production.
- Experience of start-ups and new product introduction to commercial facilities is preferred.
- Good problem solving skills, embrace problem solving tools like FMEA, 5 Why, able to work under pressure and tight timeline.
- Team player, highly self-motivated and able to work under minimum supervision.