Support the qualification and validation activities at GRAM. These duties include, but are not limited to: protocol writing, execution of study protocols, and final report generation in order to provide assurance that all Critical Quality Attributes, Critical Process Parameters, and Critical Aspects have been thoroughly tested and validated.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Responsible for preparing appropriate documentation for assigned projects in the areas of equipment, software, process, control system and critical system C & Q and validation activities.
- Acts independently with minimal supervision to conduct validation studies.
- Utilize risk assessment to identify critical areas for validation and generate test scripts accordingly.
- Review change control documents, work orders, document change requests for assessing impact on validated systems.
- Proactively and regularly communicate with the project team to update on validation status.
- Identify process improvement opportunities and equipment needs for manufacturing/packaging.
- Establish and maintain good practices with regards to processes and /or internal conditions leading to an aseptic environment.
- Demonstrate superior project management skills and leadership qualities
- Open to a flexible and fluid work environment. Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.
- Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
- Support Agency, customer, and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
- Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.
- Demonstrated project management and leadership skills.
- Ability to interpret and relate Quality and Best Practice Qualification and Validation standards for implementation and review.
- Application knowledge of statistical tools and ability to analyze and interpret data and draw conclusions.
- Ability to effectively lead projects of broad scope.
- Ability to meet scheduled timelines.
- Ability to work with a diverse customer base.
- Strong attention to detail; Ability to complete tasks with accuracy and efficiency.
- Portrays appropriate levels of integrity and professionalism.
- Excellent written and verbal skills; Ability to communicate effectively with management, staff, and regulatory agencies by exhibiting excellent interpersonal skills.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented and efficient; Acts with a sense of urgency.
- Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged.
- Ability to work well independently and in a cross-functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel, and Outlook. Knowledge of GAMP5, ISPE Baseline Guides for Commissioning and Qualification and ASTME2500.
Qualified candidate have attained a Bachelor’s Degree in Engineering, Life Sciences, or related field. A minimum of 5-8 years’ related work experience in a pharma, biopharma, and/or biotech manufacturing environment is preferred.