QA Specialist - Third Party Quality Assurance

Cipla•Central Islip, NY

About The Position

Drive the strategic imperatives and operational performance of the quality assurance function at a external manufacturing site to ensure implementation of quality systems and successful delivery of business strategy while adhering to regulatory compliance at the site.

Requirements

B. Pharm/ M. Pharm or A Bachelor’s degree (BS or BA) in Chemistry or related technical/physical science from an accredited college/university is required.
Minimum of ten (10) years of relevant experience in a Pharmaceutical FDA regulated industry in Quality Assurance and Compliance.
Minimum of five (5) years’ experience of quality management in a pharmaceutical company.
Minimum of three (3) years relevant experience directing work in a group setting.
Solid project management skills and experience is required.
Must have working knowledge of cGMPs, CFR (210/211/ 820/4), ICH and applicable international. regulations/guidelines.
Experience with Quality Systems such as electronic deviation and documentation management systems, SAP, and serialization as well as conducting Quality audits.
Should be willing and able to travel (maximum time) at external manufacturing sites as per the project plan and execution of batches.

Nice To Haves

A master’s degree in a field to study relevant to the position is preferred.
Experience working in pharmaceutical QA is preferred.
Proficiently speak and write English as a first or second language.
Bi-lingual in the Spanish language (speaking, writing, interoperating and translation) is preferred.
Proficiently communicate and understand (read and write) scientific / regulatory based ‘work” in English.
Have excellent organization, learning and teaching skills required to work in teams.
Strong desire towards continuous improvement.
Know how to use Microsoft Office programs and other scientific based software
Experience with external pharmaceutical manufacturing, packaging, testing and devices is desired.
Experience with sterile products and devices will be added advantage.

Responsibilities

Establish integration of Cipla Quality System with respect to Quality Operations at External/ Contract Manufacturing Site (CMO).
Develop and maintain a Quality Management System (QMS) at External Manufacturing site, ensuring compliance with 21 CFR Part 4 and part 820 regulations for combination products.
Implement QMS improvement initiatives based on the review of CMO's existing system.
Implementation of Cipla's corporate procedures at CMO as required to meet regulatory standards.
Ensure equipment and software compliant with 21 CFR Part 11 at CMO.
Manage QMS documentation review (Change control, Deviations. OOS and other investigation) received from CMO.
Ensure the implementation of global Corrective and Preventive Actions (CAPAs) as decided to be implemented at the External Manufacturing Sites.
Plan and monitor the quality assurance activities at site by conducting site visits meetings / interactions meetings with team members and cross functionl teams and reviewing status of shop floor activities to ensure all technical issues are resolved in time for smooth shop floor operations as well as in Quality control laboratories.
Lead, support, and guide a quality team at CMO to ensure smooth operations across shop floor manufacturing, packaging, testing, validation, and qualification activities.
Prepare, review, and approve protocols for transportation study..
Visit at site and monitor the batch manufacturin as per shceduled plan based on business need.
Review and approve master batch records and executed batch records & tetsing timely for release.
Ensure the timely issuance and review of logbooks across all departments.
Review of Batch release documents received from CMO.
Monitor daily observation rounds and ensure prompt closure of all discrepancies whenever visiting site.
Preperations and periodic review of Quality Technical Agreements with CMO.
Resolve the queries / problem faced during investigations of the non-conformances by interacting with CMO investigation team and by trouble shooting the matters by visiting sites, in order to ensure that all the non-conformances are timely and correctly investigated and documented.
Assist in the effective investigation of deviations, incidences, laboratory non-conformances, and effectiveness of CAPAs.
Review documentation for each investigation, including CAPAs, and implement best practices for addressing non-conformances.
Monitor the timely closure of change controls, deviations, OOS, OOT, and CAPAs.
Hold weekly meetings with the CFT and CMO to track investigation progress and provide input to ensure adherence to target closeout timelines.
Offer technical to CMO through periodic meetings, on-demand interactions in coordination with cross functional team including but not limited to R&D, RA, Supply Chain etc.
Drive the effective usage of cGMP based policies, systems and procedures at the site by ensuring implementation of all required SOPs in order to ensure that individual activity is performed in compliance to GMP and regulatory requirements.
Review and evaluate regulatory guidelines and updates, ensuring the implementation of corresponding procedures at the site.
Participate in Quality audits at Vendors/ suppliers or service providers supplying materials or services to InvaGen.
Plan, Prepare Schedule for Due Deligience and periodic audits at contract manufacturing sites.
Monitor the adequacy of compliance for periodic inspections, safety audits, unit operations, and regulatory audits, driving improvements in the system.
Ensure the implementation of enhanced processes and corrective actions based on audit findings.
Coordinate and support corporate function for conducting visits/ audits at different manufacturers as per the request.
Identify, assess, and simplify complexities in shop floor processes while providing technical guidance to the team.
Ensure timely escalation of any non conformances, delay in the plan at site for smooth functioning of operations to meet production plan and achieve manufacturing OTIF within time and budget.
Timely communicate with cross functional team including but not limited to Supply chain Management/ Project Management for non-confirmances reported by CMO.
Arranging or participating in meetings for project planning and executions.