Sr Technical Writer
Sr Technical Writer
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Job Description
Who are we
Fulcrum Digital is an agile and nextgeneration digital accelerating company providing digital transformation and technology services right from ideation to implementation. We specialize in delivering complex digital commerce ecosystems to large and small customers through a teamoriented and collaborative work environment. These services have applicability across a variety of industries including banking & financial services insurance retail higher education food health care and manufacturing.
The Role
As a Portfolio / Service Offering Content Creator you ll play a pivotal role in shaping our company s brand image and effectively communicating our solutions to clients. Your creative prowess technical acumen and attention to detail will be instrumental in producing highquality content across various formats.
As a Sr. Technical Writing GxP Specialist you will play a key role in supporting the implementation of for a health care customer product delivery. You ll work closely with both internal and customer teams to contribute to milestone achievements related to facility utility and equipment qualification.
Required Competencies:
Knowledge Skills & Abilities:
Exceptional technical writing skills including proficiency in Microsoft Word formatting ensuring the creation of technically accurate documents in line with validation programs.
Processoriented with strong critical thinking and problemsolving abilities.
Indepth understanding of GXP requirements and good documentation practices within the pharmaceutical industry.
Experience in creating Standard Operating Procedures Work Instructions Risk Assessments and authoring/validating commissioning/qualification/validation deliverables.
Ability to handle protocol deviations conduct investigations and implement corrective/preventive actions.
Strong organizational skills to manage multiple tasks in a fastpaced environment.
Excellent written and verbal communication skills with the ability to present information clearly and interact effectively with crossfunctional teams.
Key Responsibilities:
Develop and execute commissioning qualification and validation documents for manufacturing equipment utilities and facilities.
Handle protocol deviations investigations corrective actions and change controls as needed.
Write detailed procedures for the operation cleaning and maintenance of equipment.
Ensure all documents comply with company standards and policies.
Provide excellent customer service and foster positive relationships with team members and site customers.
Education and Experience:
Any Bachelors or Master s degree (Preference for degrees in science or engineering)
As a Sr. Technical Writing GxP Specialist, you will play a key role in supporting the implementation of for a health care customer product delivery. You ll work closely with both internal and customer teams to contribute to milestone achievements related to facility, utility, and equipment qualification. Required Competencies: Knowledge, Skills & Abilities: - Exceptional technical writing skills, including proficiency in Microsoft Word formatting, ensuring the creation of technically accurate documents in line with validation programs. - Process-oriented with strong critical thinking and problem-solving abilities. - In-depth understanding of GXP requirements and good documentation practices within the pharmaceutical industry. - Experience in creating Standard Operating Procedures, Work Instructions, Risk Assessments, and authoring/validating commissioning/qualification/validation deliverables. - Ability to handle protocol deviations, conduct investigations, and implement corrective/preventive actions. - Strong organizational skills to manage multiple tasks in a fast-paced environment. - Excellent written and verbal communication skills, with the ability to present information clearly and interact effectively with cross-functional teams. Key Responsibilities: - Develop and execute commissioning, qualification, and validation documents for manufacturing equipment, utilities, and facilities. - Handle protocol deviations, investigations, corrective actions, and change controls as needed. - Write detailed procedures for the operation, cleaning, and maintenance of equipment. - Ensure all documents comply with company standards and policies. - Provide excellent customer service and foster positive relationships with team members and site customers. Education and Experience: Any Bachelors or Master s degree (Preference for degrees in science or engineering) 5+ years of experience in technical writing, with 3+ years in the pharmaceutical industry is mandatory.
Education
BE BSC Btech
Employment Type
Full Time
