Investigate quality issues within manufacturing and quality laboratories
Examine deviations, out-of-specification results, and atypical investigations
Identify root causes and suggest effective corrective action plans
Ensure all reports comply with regulatory requirements and company policies
Contribute to moderately complex projects, managing your own time to meet targets
Develop plans for short-term work activities within a team-oriented team setting
Apply skills and discipline knowledge to contribute to work within the Work Team
Make decisions to resolve moderately complex problems in standard situations
Work under supervision, following established procedures and general instructions
Periodically review work, and may review the work of other colleagues in a mentor role
Minimum Requirements :
Educational qualification: M.Pharmacy/ B.Pharmacy / B.Tech with 7 to 10 Years of total Experience.
Minimally 4 years of experience in performing the investigation (In Manufacturing, QA, OPEx).
Must have critical thinking, technical writing, knowledge in Injectable formulation.
Preferable of having Green Belt Certification.
Proven record of problem-solving and decision-making skills.
Experience in the pharmaceutical industry.
Strong background and knowledge in manufacturing, compliance, and technology investigations, processes, and systems.
Ability to work both independently and collaboratively.
Effective communication skills, both written and verbal.
Computer literate with superior skills in managing Excel spreadsheets.
Preferred Requirements :
Master's degree
Experience with investigations, including conducting and writing investigations using methodology
Familiarity with regulatory requirements and quality standards
Robust analytical and critical thinking skills
Ability to manage multiple projects simultaneously
Experience with root cause analysis and corrective action plans
Excellent organizational skills
Ability to mentor and guide junior colleagues
Strong interpersonal skills and the ability to foster a collaborative team environment
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use