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Quality Assurance

2 months ago

Davie, United States Aequor Full time

Job Description:

Core essential skills set to the considered for the role:

• Technical knowledge of computerized system/equipment preferably oral dosage manuf., facilities and utilities;

• familiar with GAMP, CFRPart11 requirements,

• good oral and written communications in English

• works independently with minimal supervision

• able to write protocol deviations and identify root cause and corrective actions

• Master’s or Ph.D. in Science, Engineering or pharmacy required (Chemical, biomedical or Mechanical preferred)

• 2-5 years of experience within pharmaceutical or related manufacturing facility

• Prefer previous experience in a manufacturing environment within pharmaceutical.

POSITION SUMMARY

Under general supervision, performs advanced journey-level duties in reviewing specifications and determining the critical aspects of facilities, utilities and computer systems, and manufacturing equipment with regard to product and process quality; prepares qualification protocols; performs technical and specialized engineering duties.

Perform and/or provide support to validate equipment for the use in manufacturing and packaging processes.

Good interpersonal, organizational, and communication skills (both oral and written) and demonstrated skills leading and working with teams to deliver projects.

Introduces, troubleshoots and audits current processes.

Has in-depth understanding of pharmacological, chemical, medical, compliance, legal, and industry factors.

RESPONSIBILITY

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, Federal and local laws.

• Reviews electrical, mechanical, and software/computer specifications in manufacturer and blue print form, and identifies critical parameters.

• Writes protocols (IQ/OQ/PQ) that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.

• Assures that protocols are approved through proper channels; writes and revises validation protocols.

• Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.

• Assures that all test data is gathered and recorded in accordance with cGMP requirements.

• Writes final reports and assures that they are approved through proper channels.ps and communicates

• Develops and communicate project timelines and status.

• Complies with all GMP and safety requirements, SOP’s and Company policies and procedures.

• Performs related duties as assigned.

• Performs periodic reviews of equipment and system qualifications, prepares summary report, and assigns CAPAs to address deficiencies. Includes reviews of change controls, deviations, work orders, IQ/OQ, URS, drawings, and FS/DS as applicable.

• Receives instruction, guidance and direction from others.


POSITION REQUIREMENTS

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Bachelor’s in Engineering required (Chemical or Mechanical preferred)

• 2-5 years of experience within pharmaceutical or related manufacturing facility

• Prefer previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries.

• Experience in development and execution of qualification protocol/reports as related to automated equipment/systems preferred.

Skills/Knowledge/Abilities:

• Concise and organized writing of technical data

• Works with multiple departments to gather and summarize findings

• Understands manufacturing equipment functional parts including control systems, mechanical components, and electrical power.

• Related experience from other industries considered

• Responding to common inquiries or complaints from internal customers, regulatory agencies and management.

• Interpreting software changes, diagrams and flowcharts, design drawings (blue prints) and/or construction drawings and specifications including but not limited to HVAC, CA, Water Systems.

• Communicating clearly and concisely, both orally and in writing.

• Strong technical writing skills.

• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and related federal, state and local laws codes, regulations and regulatory requirements.

• Pharmaceutical principles, practices and applications.

• Principles and practices of qualification and validation.

• Techniques and principles of sampling, testing and measuring of mathematical calculations.

• Mechanical and electrical concepts.

• English usage, spelling, grammar and punctuation

• Personal computer operations and Microsoft applications (Word, Access, excel, Powerpoint, Projects and Visio).

• Ensuring compliance with all company policies and procedures, including safety rules and regulations.

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