Senior Quality Assurance Officer (USA)

Experience: 8 to 12 yrs.  |  Opening(s): 2

Medcore Pharma & APPCO Pharmaceuticals focused on developing, manufacturing and distributing of generic prescription pharmaceutical products in multi-product oral dosage forms, Semi-Solids and Injectables to customers throughout the United States. We are seeking a talented individual to join our Quality Assurance at New Jersey.

JOB Description:

The Quality Assurance department plays a critical role in the daily operations of the facility. The primary function of the department is to ensure compliance with c-GMP, domestic and international, as well as direction and oversight of internal quality systems requirements for the facility. The department is entirely separate from and independent of the personnel engaged in the direction and conduct of the site operations. We are currently seeking an experienced quality assurance and compliance candidate to work on the pre-registration and commercial activities for our launch campaign.

Responsible for managing regulatory inspection responses and follow-up actions.
Responsible for the self-inspection program including the procedures, audit schedules, audit reports, and observation follow-up and closure.
Responsible for training program including procedures, tracking status, and providing training modules.
Responsible for CAPA system including procedures, tracking completion and effectiveness.
Responsible for complaint handling system, including procedures, investigations, and responses.
Support and supervise GMP upgrade projects and ensure compliance with current industry practices and standards.
Support readiness for regulatory inspections.
Maintains operational metrics related to Compliance programs and trending program for key product quality attributes.
Performs a wide variety of activities to ensure regulatory compliance of quality systems, quality procedures, quality policies and applicable regulatory requirements of R&D and Commercial operations. Develops, implements, facilitates and maintains programs and processes that ensure production of high quality products and compliance with Current Good Manufacturing Practices (cGMPs).
Manages the internal audit, CAPA, training, and compliant quality systems to meet current industry practices and cGMP. This position will be responsible for tracking and reporting completion of the site responses and commitments from audits (internal and external), tracks trends and monitors the effectiveness of actions taken. This position also assists in the development, implementation, and continuous improvement of the compliance profile of the quality systems.
Supervise QA Inspectors in the day-to-day quality control operations including:
Sampling and inspection of raw materials, labeling/packaging components and drug products.
Administer hold system for raw materials, components, API, etc.
In-process/packaged product audits.
Releasing/rejecting materials/drug products in computerized inventory system.
Provide workload prioritizations and scheduling determinations.
Provide assistance as needed to the QA inspection group relative to troubleshooting and problem-solving issues.
Monitor and coordinate retest sampling with QC lab
Maintain annual packaged product inspection program (retains)
Support product complaint inspection and investigation.
Assist in investigations and deviations.
Review/ approve (or if needed write) protocols and reports as required.
Review and approval of PD related GMP documents including, but not limited to specifications, methods, batch records, etc., as required
Minimum Qualifications:
The candidate must have a Masters in Pharmacy with around 12-15 years of relevant experience. Candidates must be self motivated with outstanding written and verbal communication skills
Medcore Pharma & APPCO Pharmaceuticals are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information,sexual orientation or any characteristic protected under applicable law.

Contact Details
Recruiter Name:HR
Contact Company:Medcore Pharma LLC
Email Address: careers@appcopharma.com
Reference Id:Senior QA-2013