Maintains and coordinates the Validation Master Plan. Assists in the development, review, execution and closure of validation protocols (FAT, IQ, OQ, PQ, VQ) by collection of raw data used as supporting documentation. Assists the Manager in the scheduling and coordination of staff to meet aggressive project timelines. Provide management oversight for the Validation efforts at Akorn, Decatur. Work towards improving validation practices and procedures; ensure site compliance with current FDA regulatory requirements. This individual must be detail-oriented and compliance-minded with an understanding of cGMP, and other FDA Guidance Documents.
This individual must have the expertise to interface with all levels of management, staff and internal departments, including outside contractors and vendors as applicable. They must be able to multitask within a high-stress environment to maintain critical timelines.
- Maintain and implement the Validation Master Plan along with a periodic progress report to the Validation Manager.
- Supervise personnel on projects being performed.
- Develop and write Standard Operating Procedures for the Validation Department.
- Coordinate training of the Validation staff.
- Able to troubleshoot validation equipment problems and validation issues in consultation with subject matter experts and management.
- Develop, execute, and summarize various qualification protocols for critical equipment, processes and systems for review by management.
- Review data generated in protocols and write reports summarizing results for protocol final approval by validation and other appropriate management personnel.
Coordinate training of new employees of the Validation Department. Additional responsibilities as required. The job may require travel to vendor sites and/or R&D facilities to complete required work. Expected travel of less than 10%.Qualifications QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must understand vague and implicit instructions and react favorably in complex situations.
- Must be mentally flexible in dealing with difficult situations.
- Must be able to handle novel and diverse work problems on a daily basis.
- Good communication, writing and computer skills.
Safety glasses, close-toed shoes and latex gloves are required in many areas within the facility. EDUCATION AND EXPERIENCE
- Bachelorâ€™s Degree in Engineering, Chemistry, Biology or related field required.
- Minimum of five years related experience and/or training or equivalent combination of education and experience.
- Prior Aseptic experience required
- Experience in generation and execution of qualification protocols for validation of pharmaceutical processes, systems and equipment, programming and operation of data loggers, i.e.,â€Kaye Digistripsâ€, and basic computer skills.
- Previous supervisory experience preferred, but not required.
- Combination of Education and Experience may be considered equivalent.
- All full-time employees are required to work a 40-hour week. At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines. All applicants must be able to meet the attendance standards.
- At least five years of previous validation experience, preferably one year in a supervisory position at a parenteral or ophthalmic Pharmaceutical facility.
PHYSICAL DEMANDS/ MENTAL DEMANDS AND WORK ENVIRONMENT
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work, and PC use.
Mental Requirements include:
Company Overview Who we are?
- Ability to apply deductive reasoning and understand complicated issues.
- Ability to receive instructions and follow work rules including company policies.
- Ability to ensure safety and security practices.
- Ability to meet deadlines and effectively deal with office stress.
- Ability to accurately communicate ideas, facts and technical information.
- Maintain confidentiality of certain information.
Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patientsâ€™ lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akorn.com . Why choose us?
Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!What do we offer?
- Competitive pay
- Growth and development opportunities
- Tuition Reimbursement
- 3 weeks PTO + Personal Days
- 9 company holidays
- 401K match
- Medical, Dental and Vision Benefit Options
- 100% Paid Maternity Leave
- Fast paced, family-oriented work environment
- Wellness Program
- Inclusive and diverse culture
- Adoption Assistance
- Flexible Spending Accounts
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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