QA Analyst I - QMS

Job Title: QA Analyst I - QMS

Department: Quality Assurance Quality Management Systems

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.

Job Summary : The QA Analyst I for Quality Management Systems (QMS) will provide a broad scope of technical knowledge to analyze risk, troubleshoot complex issues, support quality systems and plant compliance. They apply expertise and knowledge to support change and risk management, including application of scientific and technical innovation as it pertains to clinical and commercial manufacturing. They are accountable for the execution of daily activities as related to the training program, QMS records, SOPs etc. They will support regulatory as well as internal/external inspections/audits.

Primary Responsibilities:

· Manage the training efforts/program for the Baltimore site including leading the development, coordination and presentation of training materials from initial concept to program completion as required.

· Assist in creating and maintaining the quality programs for the Baltimore site

· QA review and approval GMP documents (SOPs, BPRs, TMDs, etc.) in the Electronic Document Management System (EDMS)

· Support Regulatory and Internal Inspections/Audits

· Support Supplier/Vendor audits as required

· Own QMS records (Deviations, CAPAs, Change Control) as required

· Execute daily activities that support documentation compliance and traceability to all executed activities.

· Collaborate with team members and site customers to ensure timely deliverables for documentation and training objectives.

· SOP generation and review, providing subject matter expertise to other document authors on site

· Must be capable to work independently and strategically to ensure day to day activities are carried out in support of the business goals

· Frequently interacts with direct manager, peers, internal customers, and other cross functional peers across Emergent

Education & Qualifications:

§ Bachelor’s Degree in Scientific or related fields

§ A minimum of five (5) years of cGMP in a QA environment in Pharmaceutical industry

§ Commercial manufacturing experience (large molecules) required

§ Experience with US, EU pharmaceutical regulations and ISO standards

§ Familiarity with Trackwise

§ Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.

§ The ability to coordinate multiple priorities in a fast-paced environment

§ Excellent organizational, analytical and problem-solving skills

§ Knowledge and application of GMP principles

§ Excellent communication skills with the ability to interact with all levels throughout the organization

§ Must be a team player and work collaboratively in a complex matrix environment

Additional requirements for this role: Type/keyboard, visual acuity, stand, walk, sit, squat/kneel, sense of hearing, and lift/carry 15 lbs. Use phone, fax, copier and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, plan, communicate and prepare written communications.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.