Back to jobsExcellent communication skills, drive, and sense of urgency
Excellent computer skills, specifically Microsoft Office Suite.
Solid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives.
Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.
Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.
Knowledge of pharmaceutical manufacturing and related documents.
Knowledge and experience writing, revising and creating cGMP records and SOP’s.
Knowledge of GDP.
Creation and maintenance of batch record and cGMP documentation templates.
Closure of any compliance related CAPA’s.
Hands-on experience facilitating problem solving and root cause investigations in a pharmaceutical environment - Develops, implements, and assesses solutions for complex problems.
Ability to work effectively both independently and as part of a team.
Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
Experience using SAP business system and applications is a plus.
Experience in Inhalation products (MDI) is a plus.
Knowledge and handling of deviation, CAPA, change control, FMECA, OOS, OOT, training and OOAC.
Knowledge and handling of SAP system, master control and TrackWise system.
Knowledge of preparation of BMR and eBMR.
Knowledge of preparation of SOP and eLog books.
During audit part of team.
Planning of batches as per production plan.
Knowledge of audits and compliance.
