Vernalis Therapeutics, Inc. operates from our headquarters in Berwyn, PA.
We operate an equal opportunities employment policy. We welcome applications from suitably qualified candidates for the position(s) listed below.
Pharmaceutical Quality Operations Analyst
Department: Pharmaceutical Quality Operations
Reports to: Director, Pharmaceutical Quality Outsourcing.
This role reports into Pharmaceutical Quality Operations as the primary focus of the role is documentation management and quality. The role manages all active and archiving processes for Vernalis Therapeutics, Inc. and will support tasks in Quality and Regulatory Operations. The incumbent will manage the documentation aspects of the VTI Quality Systems including the Product Complaint System. Manage priorities per deadlines.
- Assist with implementation and ongoing support of the Quality Management Systems and all associated documentation requirements for the company and defined business units.
- Support FDA, external agency, internal and customer correspondence and audits as required.
- Interface with personnel of other departments and/or functions to assist in the completion of activities necessary to sustain the business and to provide for efficiency of operations.
- Support the Document Control Systems, including Issuing and logging of controlled document such as Standard Operating Procedures, Forms, Vendor Files, Change Controls, Quality Agreements, Stability documents and similar document management programs as directed by QA Management.
- Write, review and edit documents to ensure accuracy and completeness, e.g. SOPs
- Ensure efficient manual and electronic filing systems
- Maintain the documentation in support of approved suppliers and those under evaluation
- Prepare and/or revise procedures defining quality assurance operation activities
- Quality oversight for product inventory
- Quality oversight (write, review and/or approve stability protocol and reports)
- Act as training system administrator to manage training requirements and training records associated with Document Control Systems and GMP company training needs. Provide training in quality in systems as required.
- Support and Administer the Complaint System.
- Administer the Outsourced Product Change Management Program.
- Change control administration for all change control support (e.g. specifications for raw materials, drug product intermediates and finished drug products, validation protocols and reports, master production and packaging records, cleaning records, and analytical methods).
- Track metrics on quality documentation: change controls, deviations, complaints, audits, product releases and rejections and other Key Performance Indicators.
- Administer and Support the GMP Training Program.
- Serve as a training system administrator to manage training requirements and training records associated with the currently paper-based Document Control Systems and other company training needs.
- Administer and/or Support the Product Management systems
- Execute the company and defined business units material release procedure(s)
- Oversee the Product Inventory for destruction and rejects.
- Maintain schedules as well as review and approve APRs
- Evaluation of Pharmaceutical Quality Operations processes to identify opportunities for continuous improvement.
Minimum Qualifications: Bachelor's degree in related field from an accredited college or university and three (3) to eight (8) years of quality assurance, preferably in a pharmaceutical environment, or an equivalent combination of training and experience. Understanding of FDA regulations is a must. Understanding of international regulations is a plus
- Preferred that candidate have at least a BS degree. (Science, engineering, or pharmacy.)
- One or more certifications by the American Society of Quality, or ISO certification is a plus.
- At least three (3) years of experience in quality in regulated industry (pharmaceuticals or medical devices) is desirable. Experience with oral dosage forms is a plus.
- Excellent written and oral communication skills (in English) are absolutely essential.
- In-depth knowledge of the current Good Manufacturing regulations governing product lifecyle.
Key Skills and Personal Qualities:
The role requires a conscientious and highly organized approach.
In addition, the role requires:
- Good computer skills (for example, Word, Excel, Adobe Professional).
- Knowledge of GMP quality systems, predicate rule, FDA/ICH guidance documents and pharmaceutical company practices.
- Must display the ability to work independently with little or no supervision and plan and accomplish set goals.
- Excellent written and oral communication skills (in English).
- Good organisation skills and the ability to prioritise and manage multiple tasks.
- The ability to maintain focus with good attention to detail.
- The ability to communicate effectively with technical, regulatory and quality assurance personnel both within and outside the company.
- Excellent interpersonal skills and a willingness to co-operate and interact with diverse groups.
- The ability to take-on additional responsibilities as they arise in the performance of this role.
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Vernalis Therapeutics, Inc. offers a competitive salary and comprehensive benefits package.
To apply please send your CV and a covering email outlining why you feel you are suitable for this position to firstname.lastname@example.org
** Please submit application by April 3, 2016. **
Vernalis Therapeutics, Inc. is an Equal Opportunity Employer (EEO).
If no vacancies are listed at this time, please check back regularly if you are interested in working with Vernalis.