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Cipla · 10 hours ago

QA Specialist - Third Party Quality Assurance

Central Islip, NY

Full-time

Onsite

Senior Level, Lead/Staff

$73K/yr - $94K/yr

10+ years exp

Cipla is a leading global pharmaceutical company dedicated to high-quality medicines. They are seeking a QA Specialist to drive quality assurance functions at external manufacturing sites, ensuring compliance with regulatory standards and effective management of quality systems.

BiotechnologyHealth CareManufacturingMedicalPharmaceutical

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 functional 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

Qualification

Quality Management SystemCGMP knowledgePharmaceutical QA experienceQuality auditsRegulatory complianceSAPProject management skillsMicrosoft OfficeContinuous improvementBilingual in SpanishTeamwork skills

Required

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

Proficiently speak and write English as a first or second language

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

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