Manager, Investigation Program Quality Systems
FITS LLC Manatí, PR
- Expired: over a month ago. Applications are no longer accepted.
Our company specializes in providing Integrated Engineering, Maintenance, Utilities and Specialized Technical Services for the Pharmaceutical, Parenteral, Chemical, & Medical Devices Manufacturing business sectors in compliance with Federal Government Regulations.
Qualifications and Skills
- Bachelor of Science in Natural Science (Chemistry, Pharmacy, Biology, Engineering or a related pharmaceutical science). Master’s Degree in Science preferred.
- Eight (8) years of progressive managerial experience within the quality assurance function of the pharmaceutical/health care industry and regulatory agencies,
- Five (5) years of experience in aseptic filling and finishing areas for liquid and lyophilized products and medical devices.
- Ability to develop and apply operating philosophy and to operate within Company policies and procedures within Manufacturing, Quality and Compliance, Marketing and Regulatory areas.
- Proficient in cGMP’s and FDA regulations and requirements.
- Experience in containment technologies.
- Understanding of the business and marketing aspects of pharmaceutical operations in a highly regulated industry is extremely important for evaluating the potential impact of product decisions.
- Excellent verbal, written and presentation skills and have the ability to deal effectively with all levels of management.
- Must be innovative and creative and utilize all available resources.
- Working knowledge in PC’s and electronic tools.
- Excellent communication skills in both English and Spanish.
- Demonstrated critical thinking skills
- Excellent technical writing and presentation skills
Responsibilities and Duties
- Ensures robustness and approves investigations and process deviations or incidents where quality standards of a product or its validation may be questionable.
- Ensures sound discussions on training adequacy and CAPA effectiveness.
- Support data trending and demonstrates a healthy (robustness) of the investigation program.
- Drives for continuous improvement and develops countermeasures to address deficiencies at investigation program level.
- Facilitates the governance of the investigation program to address all above responsibilities.
- Maintains communication with internal & external customers to ensure compliance & timely completion of investigations activities.
- Support the Quality Assurance investigation function during FDA, corporate GMP’s and customer’s compliance audits.
- Reviews and approves the standard operating procedures.
- Supports the QC/QA efforts during the transfer and validations of parenteral products at the site.
- Assures the compliance of the following processes required and activities: implementation of corporate policies, guidelines and new regulatory requirements, manufacturing of clinical and stability lots in accordance with cGMPs, corporate and regulatory guidelines, compliance of release/commercial product with the regulatory guidelines, policies and cGMPs and procedures for evaluating lots records are in place.
- Supports all site Initiatives and any other assignments / project based on business needs.
- Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.
- Reviews and approves all executed batch production records and laboratory testing records before release of the product for distribution to assure that no deviations have occurred, or if deviations have occurred, that they have been fully investigated.
- Ensures effective process /system for disposition of finished products & involvement in the decision for drug products disposition.
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