Responsibilities:
1. Generates commercial and experimental Batch Records for Production.
- makes copy from Bath Record Master File
- prints all applicable documentation from Document Control and Archiving (DCA) and SAP systems.
- prints label (lot number, product code and name and other additional information).
- assigns seals to be placed on the final product drums (Compression, Coating and Printing)
- compares batch record and all batch record documentation versus production orders and BOM/BOS to assure the documentation corresponds to the product lot.
- verifies that batch records, production orders and BOM/BOS data are the same if not report any
discrepancy immediately to the corresponding department (MT or Materials) for prompt correction before
distribution for manufacturing process
2. Generates cleaning checklist packages and distributes to Manufacturing supervisor ensuring that the cleaning forms are the current version approved in DCA.
3. Receives and reviews daily executed Batch Records, removes internal documentation and keeps all GMP documentation required by BMS procedures and refers to the supervisor any document’s discrepancies for correction before delivering to QA area.
4. Gives follow up to manufacturing areas to ensure documentation cycle time completion, production schedule commitment and reports any finding to the release attainment team.
5. Performs periodic manufacturing documentation audits as scheduled.
6. Verifies approved Packaging Art Components (BOS- Bill of Specification) and creates labels accordingly.
7. Maintains Master Batch Records, executed Batch Record, Log Books, cleaning registers/checklists, new and executed forms, security seals, printed materials and any batch record supporting document.
8. Receives and makes reconciliation of manufacturing container seals by number according to Security Guidelines and GMPs.
9. Coordinates with Purchasing Department Printing Forms Requisitions and maintains an adequate supply of forms and logbooks for the Manufacturing area.
10. Performs the reporting consumption of material, man hours, transfer orders (TO) and transfer request (TR) in absent of the Manufacturing Coordinator.
11. Maintains Building 6 Procedures Binders and procedures matrix to ensure that latest approved version are in place and, replace any obsolete version. This include the reconciliation and removal of obsolete versions.
12. Assists on Internal/External audits by providing any required documentation as the manufacturing documentation custody.
Knowledge:
Bachelor Degree with at least One (1) year of experience in manufacturing documentation or Quality Control administration in a Pharmaceutical industry or
Associate Degree with at least two (2) years of experience in manufacturing documentation or Quality Control administration in a Pharmaceutical industry
Computer knowledge is required (Word, Excel, PowerPoint, Internet)
Skills:
Excellent communication verbal and written skills (English/Spanish).
Excellent analytical skills with details
Good mathematical skills
Team Player and ability to work with people at different levels.
Typing and Filing skills
Excellent organization skills
Self-starter and motivator.
Able to work with minimum supervision.
Good proof-reading skills.
Good knowledge of office machines, such as fax, copiers, etc.
Concentration and Visual Effort
It is extremely important to pay close attention to details since information being generated and revised is of a compliance and regulatory nature. Accuracy and visual concentration are required when reviewing executed batch records and preparing reports and other documents.
Needs to interprets manufacturing data
Decision Making / Latitude:
Some decision making is required to determine priority task in the application of complex SOP's and other procedures.
Must decide on and identify documentation trends that may lead to proactively minimize production approval delays or impact on supply chain.
Advise supervisors of any problem or potential problems that may arise.
Interaction:
Daily communication is required with Manufacturing, Planning and QA & Compliance personnel. Incumbent is responsible for reporting to the supervisor any discrepancy observed.
Occasional contact with upper management may be necessary.
Errors:
Possible errors may have significant impact on shipping schedules and customer service efforts.
Refrain from providing information to unauthorized personnel or outside persons.
Avoid undue delays in processing documents that requires immediate attention.
Prevents documents miss filling.
Absolutely refrain from disclosing confidential information to anyone.
Errors will have an impact in Supply Chain & Regulatory.
Working Conditions:
Able to work under pressure and availability to work overtime and rotating shifts when required.
Non-hazardous working environment
Non require travel on exceptional basis
Supervision Exercised:
Incumbent works with minimum supervision
