Validation Specialist

GENERAL DESCRIPTION

A Validation Specialist is mainly responsible for planning, scheduling, executing, and leading various validation project assignments. The validation assignments include designing, development, validation, qualification and implementation of both the existing and new facilities, products, utilities, equipment, processes, instrumentation systems etc. Validation Specialist is responsible for leading cross-functional project teams in the devising, implementation and development of validation plans and protocols. 

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactory.  Essential job functions and duties include, but are not limited, to:

* Manage client relationship and ensure appropriate and timely communications are maintained

*  Assist regulatory affairs in providing situational compliance and risk assessments

*  Involve in qualification /validation of equipment and utility systems such as water systems, incubators, Refrigerators, Freezers, Autoclave, HVAC, Facilities

*  Provide guidance and training to the operations personnel for assisting in the execution of qualification/validation related testing

*  Coordinate all validation activities with external (client) departments, and assure that all validation activities are performed in compliance with approved validation/qualification protocols, standard operating procedures and current Regulatory requirements/guidelines

*  Assist in providing information updates and managing Project Team expectations

*  Facilitate problem solving either functionally or cross functionally

*  Know the key risk area and ensure that they are appropriately managed and communicated

*  Track project progress against agreed plans. Identify early any deviation from the agreed schedule and implement actions to keep the project on schedule

*  Ensures implementations of agreed changes to plans

*  Review all data from the stability studies and analytical method developmental studies and conduct trend analysis on new drug products

*  Assist in the preparation of FDA filings (Quality sections of Investigational Drug Applications (IND’s), IND Amendments, and New Drug Applications (NDA’s)

*  Review and analyze trend data such as environmental data and water test result etc.

*  Follow established department SOP's, cGMP regulations, and batch record instructions.

*  Complies with all Company policies and procedures, including safety rules and regulations.

*  Maintains a safe work environment and operates in a safe manner.

*  Perform other related job duties related to the job, as assigned by management.

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skills, education, and/or abilities required for the job:

*  Manage product development activities related to method developments, qualification, and validation activities.

*  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

*  Proficient skills in reading, writing, and speaking in English; bilingual (English/Spanish) skills a plus.

*  Excellent written and oral communications skills & techniques.

*  Basic math skills; proficiency with 10-key calculator.

*  Effective planning & organizing skills; ability to handle multiple task/duties.

* Proficient PC skills (Microsoft Word, Excel, Powerpoint).

*  Effective problem-solving skills.

*  Ability to work independently and in a team environment.

* Knowledge of general office skills and administrative procedures, including, but not limited to: typing (min. 45-50 wpm), filing, copying, faxing, editing, and development of memos, letters, reports, and correspondence.

*  Ability to maintain a positive, professional, cooperative demeanor, conduct, and working relationship with peers, management, employees, and other individuals that interact with this position.

*  Ability to comply, interpret and support Company policies, procedures, work rules, and protocols.

*  Ability to adapt effectively to workplace changes and new job duties/responsibilities.

*  Ability to represent the Company in a positive and professional manner at all times.

SELECTION GUIDELINES

The appropriate knowledge, skills and abilities required for this position are achievable through the following combination of education, work experience and training:

*  High School Diploma or equivalent GED Certificate; and

*  The ideal candidate must have a BA/BS in Science and /or at least 5 years pharmaceutical and/ or nutritional or related industry in a quality system, validation or an advance degree and 2+ years of experience

*  5 or more years of work experience in a fast-paced  work environment; or

* Any combination of experience, education, and training that provides the level of knowledge, skills, and experience needed to successful perform the job.

PHYSICAL DEMANDS & WORKING CONDITIONS

The essential functions of this job require the employee to perform the following physical activities during the course of work: 

*  Communicates orally with management, employees, co-workers, vendors, suppliers, governmental compliance agencies, and the general public by telephone or in person, in one-on-one or group settings.

*  Regularly uses a telephone, computer (e-mail) and fax for communication.

*  Required to stand, walk, and sit for extended periods of time during the course of work shift.

* Routinely required to stoop, bend, kneel, lift, and reach, in the performance of job function.

*  Requires the essential use of hands, speech, eyesight, and hearing.

*  Requires agility to operate multiple telephone lines with the use of hands and head-set.

* Lifting limitations for this position: 25-30 lbs.

*  Vision requirements include close and distance vision, color vision, peripheral and depth vision, and the ability to adjust focus as needed.

*  Requires incumbent to sit and operate computer for extended periods of time during course of work day, and the ability to proficiently use the computer key-board for typing.

*  Noise level for this work environment is typically low to moderate.

*  Periods of odoriferous environment.

Note:  The Company reserves the right to modify, update, change and/or make corrections to this job description, at the sole discretion of senior management, at any time during the employee’s employment term, at the sole discretion of management.

Best Formulations is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Best Formulations will work with applicants to meet accommodation needs that are made known to Best Formulations in advance.