Associate performs/ supports process development studies and process validation activities. This position also prepares technical documentation to support development and validation program at Sun Pharma. This position provides technical support to Manufacturing and Quality department.

Area Of Responsibility

• Design and execution of DOE’s, process optimization studies, and process qualification batches, Process data compilation and analysis using statistical tools.
• Develop a strong documentation package, involving from conceptual study to various phases of product development like process study, characterization, process qualification and cleaning validation.
• Responsibility for preparation of Master batch records, Exhibit Batch protocols, pre-validation and process validation documentation and reports.
• Provide troubleshooting support to manufacturing operations.
• Champion compliance investigations, commitments (CAPA), and change controls.
• Participate on cross-functional team that address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships.

Work Conditions:

Office Environment located within a Manufacturing/Production facility.

Environmental related to manufacturing/production environments:

• Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
• Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
• Odors: Unpleasant smells.
• Gases: Examples include carbon monoxide and ozone.
• Dust: Airborne particles of any kind, such as textile dust, wood, and silica.
• Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.

Physical Requirements:

• Moderate physical effort equal to frequent lifting or moving of lightweight materials up to 10lbs.
• Ability to navigate office and plant floor working environments, stands, ambulates, and reaches.
• Ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Education and Job Qualification

• Minimum B.S. in relevant science field, Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related disciplines. M.S. preferred.
• Proficient in MS office applications (Word, Excel, Projects, PowerPoint).
• Good interpersonal, oral communication and technical report writing skills.
• Analytical thinking and problem solving skills.
• A self-starter with a hands-on approach and a can-do attitude.
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

Experience

• Minimum one year of industry experience, ideally with solid oral dosage development.
• Process qualification, process validation, and cleaning validation experience considered.
• Master’s degree considered in lieu of experience.