Senior Quality Assurance Specialist, Rensselaer NY The Senior Quality Assurance Specialist with guidance from the site Quality Assurance Manager, ensures proper implementation of the quality systems at the site, maintains them current and in line with applicable regulation and Corporate standards.
The Senior Quality Assurance Specialist oversees the site quality compliance and makes recommendations for corrective action necessary to ensure conformity, driving continuous improvement initiatives.
Leads Regulatory Agencies inspections and Customer audits.
Oversee SOP, training document and records management systems.
MAJOR DUTIES AND RESPONSIBILITIES Assist the Quality Assurance Manager in ensuring compliance with all Regulatory Agency requirements (e.g., FDA, EMA, MHRA, etc) for the Rensselaer site Develop and/or review and/or approve quality standards, policies, and procedures for all functions and departments involved in cGMP activities.
Support all the Regulatory Agency inspections at the site and the preparation of CAPAs, and monitor their completion providing regular updates to management.
Manage all the customer audits at the site, lead the preparation of CAPAs, and monitor their completion providing updates to customers and management.
Report serious or repeated observations or serious compliance gaps to Head of Quality Assurance.
Maintain evidence files for all regulatory inspections and customer audits.
Manage the Internal Audit program including coordination of auditors within the QA department.
Interact with the AMRI Quality network to share information related to quality expectation, inspections, audits, facilitating harmonization of quality system within AMRI.
Education and/or Experience Minimum Bachelor of Science degree in Chemistry or a related field Minimum 5 years QA, RA or Compliance experience in pharmaceutical industry (preferred in APIs) at USFDA regulated facilities Broad knowledge of cGMP, FDA and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH).
Knowledge of pharmaceutical processes.
USFDA inspection experiences (participating or leading) Auditing experience is preferred Prior supervisory experience is preferred Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross functionally across internal stakeholders.
Proficient in building consensus, negotiating and escalating issues Good understanding of the importance and use of quality metrics
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