Quality Assurance Consultant
Job Posting for Quality Assurance Consultant at DSI InPharmatics
ProductLife US is seeking a Quality Assurance Consultant to be responsible for Batch Record Review, Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolutions.
Qualifications
- Review of test records for batch release, SOPs, CAPAs, Deviations, change controls, etc.
- Actively drive high quality deliverables by promoting a high standard of Quality Culture,
- Determine whether quality activities and related results comply with cGMP requirements,
- Engage cross-functionally as required to manage completion of required batch record corrections by interacting with responsible parties and counseling personnel on proper cGMP documentation practices,
- Ensure that all the batch related deviation, Investigations, Nonconformance, CAPAs, and Change Control Records, are closed as a part of review process,
- Assist in QA review of the new master documents such as master manufacturing records, master packaging batch record, characterization and validation protocol’s, IQ-OQ and PQ’s etc.
- Competent problem solving, risk assessment and impact analysis abilities,
- Good writing and comprehension skills,
Required Skills
B.S. in a scientific discipline or an equivalent combination of education, training, and experience,
- Pharmaceutical experience with minimum 5 years of relevant work experience acting Quality Assurance Associate.
- Excellent knowledge of FDA guidelines and regulations,
- Perform activities with specific responsibility for GMP compliance.
Salary.com Estimation for Quality Assurance Consultant in Philadelphia, PA
$126,392 to $161,656
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Job openings at DSI InPharmatics
DSI InPharmatics
Philadelphia, PA
Full Time
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