Senior Quality Assurance Specialist

• 100% on-site position.

About MedPharm:
MedPharm is a global leader in topical and transdermal product development, providing end-to-end services from early-stage formulation development to full commercial production. With facilities in the UK and the US, MedPharm has established itself as a trusted partner in dermatological, nail, mucosal, respiratory, and transdermal drug delivery. MedPharm has a strong track record of supporting product development and pioneering performance testing models to reduce development risks for its clients.
Essential Duties and Responsibilities:

• Review and approval of change controls, deviations, OOS, CAPAs, audit comments and other related quality records and provide QA input into their generation.
• Conduct internal audits of facilities to ensure compliance to GxP (GMP and GLP) and other applicable standards.
• Maintain the quality programs for the QA department including but not limited to, document control, supplier qualification, Technical Agreement and internal/external audit program.
• Assist with the development, review, revision and issue of Quality documentation such as standard operating procedures (SOPs) and forms, via eQMS where necessary.
• Support the management of retention and archiving of records including acting as GLP Archivist and have oversight of these activities.
• Assist with hosting client and regulatory audits.
• Provide training and implement QA procedures for compliance with GxP.
• Audit raw data (and associated study documentation where appropriate) to ensure that the work has been completed to GxP.
• Maintain current regulatory knowledge, communicating information and updates to staff as appropriate.
• Approve specifications, sampling instructions, test methods and other Quality Control procedures.
• Review and approve batch manufacturing records prior to manufacture and post-manufacture.
• Review and monitor suppliers of materials and services including conduct of periodic inspections where applicable.
• Approve or reject, as appropriate, starting materials, packaging materials, and intermediate, bulk and finished products.
• Review and compile manufacturing batch records and associated data ready for QP batch release
• Oversee the activities across the QMS reporting any issues to the Director of QA and be the initial contact in the team in the absence of Director of QA.
• Line management of Junior QA staff.
• To perform any other tasks at the request of MedPharm Senior Management appropriate to the job function.

Education

• Bachelors degree with 5+ years of relevant experience, education may be used in lieu of experience

Experience/Traits/Skills

• Knowledge of batch release process and root cause analysis
• Knowledge in batch release support (review of BMRs, data etc)
• Previous experience of QMS management including deviations, CAPAs and change control
• Previous experience in pharmaceutical industry CMO, CRO or big pharma (exposure to manufacturing ideal)
• Demonstrated ability to review, revise and perform procedures associated with quality assurance and resolve issues of moderate complexity
• Must have a meticulous approach to work and be highly organized and extremely driven.
• Good communication skills both written and oral are vital
• Must be able to multitask, manage time efficiently and be able to prioritize
• Must be able to work independently and in a team environment
• Must have a proactive and self-starting approach, consistently taking initiative

Why Join MedPharm?
Our breadth of competencies has us partnering with clients from formula inception, clinical trials, regulatory filing and into commercial production. We are engaged in all stages of the pharmaceutical commercialization process, and you will work with some of the best clients in our industry’s CDMO space.
Diversity and Inclusion:
MedPharm is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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For more information about MedPharm and our recent developments, visit MedPharm's official website at www.medpharm.com.