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.