Technical Writer, Engineering Job at SUN PHARMA in New Brunswick

Job Summary

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.

Area Of Responsibility

• 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.

Work Conditions:

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.

Physical Requirements:

• 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.

Travel Estimate

Up to 5 %

Education and Job Qualification

• 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, Document Life Cycle and Audit Compliance.
• 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 of five (5) years working in a pharmaceutical environment with at least two (2) years of technical writing experience within a Pharmaceutical manufacturing environment.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.