Cipla USA · 1 month ago
PKG. Documentation Specialist II
Fall River, MA
Full-time
Onsite
Mid Level
$73K/yr - $94K/yr
4+ years expCipla USA is a leading global pharmaceutical company, and they are seeking a Pkg. Documentation Specialist II to oversee the creation and revision of GMP batch production records and SOPs. The role involves ensuring compliance with documentation procedures and collaborating with cross-functional teams to maintain operational success.
Pharmaceuticals
Responsibilities
Works with Manufacturing/Packaging to deliver timely batch record review across all shifts
Reviews and approval of master batch records
Develops appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets. Generates and reports on metrics on agreed frequency
Creates training materials for subject matter input
Track and manage periodic review of approved procedures
Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory guidance
Provides data to support management evaluation of performance trends
Owns quality records (change control, CAPA’s, deviations) and delivers to established timelines
Autonomously leads and manages projects to implement continuous improvement opportunities
Lead and/or support root cause investigations related to performance trends and formal deviations
Develop, implement and assess solutions for complex problems
Anticipates risk and builds contingencies to help mitigate impact
Reviews document for accuracy and completeness
Defends the validation programs and strategies to customers and regulatory auditors
Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols
Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment
Performs other duties as assigned
Qualification
Required
Associate degree with 4-6 years knowledge and experience of GMP documentation required
Bachelor's degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or related discipline from an accredited college/university
Minimum two (2) years documentation experience and four (4) years related pharmaceutical or biotech industry experience
Excellent 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
Knowledge and handling of deviation, CAPA, change control, FMECA, OOS, OOT, training and OOAC
Knowledge and handling of SAP system, master control and TrackWwise 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
Proficiently speak English as a first or second language
Ability to understand and analyze complex data sets
Ability to read, write and communicate effectively
Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously
Position requires flexibility to quickly adapt to changing work environment and schedules
Excellent organizational skills with the ability to focus on details
Basic computer skills (Word and Excel) – Intermediate
Good basic math knowledge and excellent attention to details
Preferred
Master's degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university
Experience using SAP business system and applications
Experience in Inhalation products (MDI)
Knowledge of statistical packages
Knowledge of good manufacturing practices and good documentation practices
Company
Cipla USA
Cipla USA, the wholly owned subsidiary of Cipla (established in 1935), has been enabling patient access to affordable and high-quality medicines in the US for over 30 years.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Arunesh Verma
President & CEO, Cipla North America
Marc Falkin
Executive Vice President / Chief Commercial Officer
Company data provided by crunchbase