Technical Writer, Production

Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

The Technical Writer will perform investigations and assist manufacturing and packaging operations on investigations, Product quality complaints. They will also assist in cross functional investigations for out of specification (OOS), out of trend (OOT), Laboratory Events, CAPAs, and change controls.

• Ensure timely closure of all manufacturing/packaging and Quality Management System records.
• Organize and participate in reviews of cross functional investigations.
• Represents Operations at cross-functional meetings.
• Work with process owners and SMEs to implement agreed upon procedural documentation and to develop cross-functional process models.
• Collect input from stakeholders and consolidate comments for conflict resolution.
• Drive the improvement in established KPI’s / metrics for manufacturing and packaging departments.
• Assist operations in responses to any internal audit, corporate audit, or regulatory audit observations involving manufacturing or packaging control.

Corporate office environment.

Manufacturing / Production environment.

Warehouse environment.

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.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to use hands to handle and feel and talk and hear. The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.
• Must be capable of bending and lifting, moving and/or carrying up to 50 pounds.
• Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
• Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Up to 5 %

• Bachelor's degree (BA/BS) in Life Sciences, Pharmacy, or equivalent required.
• Demonstrated excellent communication: verbal, written and presentation skills.
• A self-starter with a hands-on approach and a can-do attitude.
• A team building champion driving innovative cross functional synergies.
• Excellent project management and problem solving skills.
• Excellent computer skills; MS Office (Word, Excel, PowerPoint), Track wise, EDMS, Outlook.
• Knowledge of GDP, GMP, QA Documentation, QA Batch records, Quality Systems, Archiving, Retrieval, EDMS workflow,…