Lab Application & Quality Control Supervisor

at  UNITHER PHARMACEUTICALS

WHO WE ARE?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.
With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.
Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.

JOB SUMMARY:

The Laboratory Application & QC Supervisor warranties that all the laboratory systems composed of equipment, instruments and computerized systems are properly maintained, qualified and calibrated, secured to be properly used by the laboratory users, to provide a high level of confidence with the results on the products.
This position interacts as the laboratory system owner with IT group and laboratory staff the systems used in chemistry and microbiology in helping the laboratory staff with technical issues, and in training on the different system. This position links IT purposes for the lab to functional purposes. Based on a strong knowledge in testing and interest for software. It deals with the access management for each computerized system, data handling and data integrity.
This position provides recommendations for changes and improvements in the laboratory management tools, systems to be more efficient and secured.

SPECIFIC SKILLS:

Must have previous experience in cGMP environment
Ability to write stability protocols and final reports with knowledge of ICH stability guidelines
Ability to quickly learn new laboratory/stability information systems
Ability to evaluate data, perform trend analyses, identity potential issues, propose and implement solutions.
Ability to comply with SOP’s, cGMP’s, HS&E requirements, and FDA, DEA, and OSHA regulations.
Ability to work independently or within a group project team setting.
Computer Skills:
Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating and using personal folders, scheduling appointments, working with meeting requests and managing tasks.
Intermediate Microsoft Word skills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files; as well as create moderately complex documents containing tables and graphs, and ability to mail merge documents, apply page setup functions (margins, page numbers, footers, headers), create an index and/or table of contents, use search & replace, print labels and envelopes.
Intermediate Excel skills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data, link data, create and edit charts, change page orientation, add headers and footers, filter and sort lists, format data, insert rows, enter and sort data and produce graphs and charts.

QUALIFICATIONS/EXPERIENCE:

Bachelors degree in Life Sciences preferred
5-10 years of laboratory experience, in development, chemistry or stability, including validation, qualification and calibration purposes
Software and instruments interests, especially HPLC and GC knowledge
Quality Control/Assurance, Stability and GMP experience preferred.
Technical knowledge to review and analyze stability test results
Ability to write and provide input for deviations, investigations and CAPA’s as needed
Stability experience in pharmaceutical manufacturing or medical device background require

Laboratory Computerized Systems Management
Follow software upgrades and laboratory computerized systems and participate in their qualification
Manage contracted external suppliers for certain interventions
Manage user accounts and train technicians on existing software
Validate the excel calculations used in QC
Create instrument control methods
Perform system audit trails of the various systems in place
Check access at regular intervals
Ensuring compliance with data integrity requirements in the control laboratory
Laboratory Systems Technological Survey
Ensure the proper functioning of each instrument
Establish a maintenance contract with the supplier if it cannot be carried out in-house
Establish user requirement specifications for systems replacement
Manage maintenance interventions
Ensure that equipment complies with applicable standards
Ensure the condition of the equipment fleet and participate in the investment budget
Manage requests for quotations and orders for the purchase and repair of laboratory equipment
Order new equipment after evaluation and approval by the QC Manager
Laboratory Systems Calibration, Maintenance and Qualification
Define and update, if necessary, the calibration, maintenance and updates schedule(s) with the laboratory scientists and supervisors, at least annually. Approve it with the QC manager
Plan interventions with suppliers or perform checks according to the defined schedule
Manage external suppliers, when applicable
Sourcing consumables needed for operations
Perform tests or supervise the execution of tests and issue appropriate reports
Verify and sign metrological reports from our subcontractors
Write and/or evaluate deviations
Providing calibration labels
Verify and sign vendor qualification protocols and reports and/or draft protocols in-house
Providing the pre-authorization and support to Lab Operations, as needed
Write requalification paperwork in case of changes
Apply GMP training received
Quality requirements and improvements
Keep your documentation up to date
Participate and support metered instrument updates, as needed
Participate in audits and inspections and propose CAPA plan including timeline, and execute them on time
Maintain the laboratory qualification/validation/calibration master plan
Manage all your CAPA on time
Lead or participate in working sessions and projects (laboratory projects, sites projects), after agreement of your management
Analyze the processes in place and the working methods in place, and propose improvements to improve compliance and/or efficiency
Update by yourself all types of documents for your perimeter, and lead the execution of actions
Support the development of new products by participating in the development/validation/optimization of methods and by integrating new instruments
Health & Safety
Respect and ensure compliance with dressing and hygiene procedures
Respect and ensure compliance with safety instructions and various procedures
Ensure compliance with safety rules during interventions or when writing the various standards and procedures
Have an appropriate attitude that does not endanger your safety and the safety of others
Report any discrepancies or risks you may find