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Job description
Aucta Pharmaceuticals, Inc.
is a technology-based company focusing on the development and commercialization
of Branded Specialty Products. Aucta is a pharmaceutical company creating
better products of proven molecules using 505(b)(2) regulatory pathways.
Through innovation, Aucta is creating new therapeutics, including new dosage
forms, dosing regimens and indications.
Position Summary
Primary responsibility is to
ensure that the internal operation of Aucta is in GMP compliance. Ensure that
the CMOs are operating in compliance with all Aucta. and applicable FDA and
international regulatory standards. In addition, this position has responsibility
to ensure that released products comply with Aucta’s internal and government
(FDA or specific market) requirements and Maintains Quality Systems processes
(e.g., complaint investigations and change controls).
Duties & Responsibilities
Include but are not limited to:
· Manage CMO relationships from a quality and compliance perspective, including
monitoring quality metrics, performing annual risk assessment of CMOs and
executing oversight as defined by SOP, authoring and executing Compliance
Improvement Plans as needed
· Determine disposition of drug products according to Aucta and regulatory specifications
and standards
· Process/review and approve change requests generated internally or by External Manufacturers
Process/review and approve Annual Quality Product Reports authored by Contract Manufacturers
Write and manage deviations, complaints, change controls, and CAPA. Review and approve the manufacturing and laboratory investigations, deviations, or incidents and associated CAPAs
· Provide direction and recommendations as to future course(s) of action. Ensure timely closure of quality events, deviations, CAPA, change controls action plans and laboratory events/investigations.
Review and approve Quality Agreements
Approve CMO/CRO product quality complaint investigations

· Review and approve various documents, protocols, qualifications and reports related to drug products, drug substances and Quality Management System

· Write,review and implement SOPs to ensure compliance with current Aucta standard and
cGMP. Support product recalls and execute action plans as assigned

· Participate in FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements
· Assist with preparation of FDA and audit responses
· Should have knowledge on reviewing laboratory documents (method transfer,
specifications etc.). Hands on laboratory experience is much preferred.
Perform Internal and External audits of laboratory and manufacturing sites of drug products ensuring compliance with all appropriate Aucta and FDA and EMA agency cGMP regulations and policies

· Represent Quality on cross-functional teams within the Technical Transfer teams, Supplier
Selection, Serialization, and Manufacturing Launch teams

· Identify continuous improvement efforts to build quality in all aspects of the process while considering cGMP/quality compliance. Other assigned duties

· Other duties as assigned.
Job Type: Full-time
Qualifications: A minimum of 3+ years of experience in laboratory and quality assurance roles within an FDA-approved company
Benefits:

• Dental insurance
• Disability insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Work Location:

• Piscataway

Work Remotely:

• No

Work Location: In person
Address:
71 Suttons Lane,Piscataway, NJ 08854