Quality Assurance Associate ( QA Pharmaceutical)
Company: Granules Pharmaceuticals
Posted on: April 15, 2019
The QA Associate ensures compliance with cGMP and internal
policies, procedures and specifications. This position is
responsible for performing inspections, batch record review, and
quality system functions in accordance with cGMP and related
company SOPs, state, federal and local laws as applicable. This
person should be knowledgeable of cGMP requirements, FDA
regulations and ICH guidelines. This person is also responsible for
driving the site change control, site incident/deviation/complaint
investigation and CAPA programs. The persons is responsible for the
execution and oversight of the cleaning and process validation
activities as well.Responsibilities:
- Ensure products meet approved company policies, process and
- Responsible for scheduling change control committee meetings
interfacing primarily with technical, quality and manufacturing
- Perform and support maintenance and closure activities of
documents such as reports, change controls and protocol
- Drive the timely implemenation and closure of change controls
while ensuring compliance to applicable quality standards and
change control procedures.
- Author and review standard operating procedures.
- Prepare and execute cleaning validation/verification documents
along eith calculation of the acceptance critieria for all
equipment available at the site.
- Prepare and execute process validation/verification documents
and author reports for the executed process vaildation/verification
- Develops, assigns code numbers and maintains logs of all
reported incidents of non-compliance, investigations, planned and
unplanned deviations, CAPA.
- Initiating follow-up with departments involved in
- Tracks and manages the system for CAPAs, compliants,
non-conformances, and investigations. To include classificaiton of
complaints, completion of investigations, and failure analyses with
thorough and effective documentation.
- Present investigations during audits and inspections.
- Perfrm and suppor maintenance and closure activities of
documents such as reports, exceptions/deviations, CAPAs, change
controls and compliants.
- Other duties as assigned
Knowledge & Skills:--- Demonstrate knowledge in process and
cleaning validation/qualification.--- Knowledge of Quality
Management Systems, including FDA compliance standards, cGMP
regulations/guidelines.--- Knowledge of USFDA regulations/guidances
and ICH guidances.--- Knowledge of Change Control/Deviation
management and CAPA identification/implementation.--- Proficient in
Microsoft Word, Excel, Power Point.--- Ability to analyze
data/information and to assess and resolve complex issues, as
required.--- Ability to work and communicate with cross-functional
teams.--- Ability to manage multiple priorities and re-prioritize
tasks, as required.--- Flexible and able to adapt to company growth
and evolving responsibilities.--- Strong attention to detail and
excellent organization.--- Excellent oral and written communication
skills.Experience & Education:--- Bachelor Degree in a Natural
Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.--- At
least Two to five (5) years experience in a quality assurance role
in a cGMP-regulated environment.Physical Requirements:--- While
performing the duties of this job, the employee is regularly
required to, stand, sit, talk, hear, and use hands and fingers to
operate a computer and telephone keyboard.--- Light to moderate
lifting up to 10-15 lbs is required.Travel:Up to 5% travel maybe
Keywords: Granules Pharmaceuticals, Chantilly , Quality Assurance Associate ( QA Pharmaceutical), Healthcare , Chantilly, Virginia
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