Compliance Specialist - TechDigital
Devens, MA
About the Job
Hybrid- At least 50 % Onsite !
To provide operations with the appropriate service and advice to assure that site quality systems are in place for regulatory compliance. Incumbent must assure that quality systems and programs such as internal audits, annual product reviews, stability, procedures, change controls, gap analysis, complaints, and other are in compliance with GMP regulations. This position must comply with all Security Guidelines, Environmental Health and Safety regulations and current Good Manufacturing Practices required by the job function. the incumbent works with minimum supervision and additional working hours, when required. 1. Assures the site quality systems are in place to avoid any possible regulatory compliance situation at the Site.
2. Manages the different quality systems and programs established at the site such as but not limited to Change Control,
Packaging change controls, Stability, Policies and Directives, Gap Analysis, Customer Complaints, TrackWise System, Site Gatekeeper, Regulatory CMC, Internal Audits, Document Control, External Audits, Annual Product Quality Review, and others handled by the Compliance areas as assigned.
3. Prepares Annual Product Quality Reviews report for each pharmaceutical finished packaged and bulk drug products manufactured at the Site as per established timelines.
4. Reviews and prepares regulatory documentation intended for government regulatory agencies (e.g. FDA), such as master files, new and existing product registrations, regulatory submissions, foreign countries registrations, certificates, etc.
5. Reviews, evaluates and approves plant operating documents such as SOPs, change control, qualification reports, CAPA, and process deviations and maintains documents in an organized and traceable manner.
6. Evaluates specifications, documents, protocols, registrations and recommends actions to assure regulatory compliance.
7. Provides assistance in managing all aspects of regulatory and corporate inspections and participates actively during inspections and audits including performing readiness exercises before and during inspections/audits.
8. Evaluates and recommends lots to be placed on stability, evaluate trends, and performs investigations when required.
9. Ensures compliance with procedures, policies and directives to avoid regulatory issues performing Gap Analysis on Client documents and observational findings from the pharmaceutical industry.
10. Provides advice and service to all operating departments to assure compliance with cGMP's and other regulations.
11. Investigates customer complaints, issues the corresponding reports indicating possible cause and recommending solutions.
12. Conducts and/or prepares training materials on GMP topics.
13. Performs formal internal audits and pre-approval inspections of manufacturing, laboratory and warehouse operations for cGMP's compliance and, reports and follows up on observed deficiencies on a regular basis.
To provide operations with the appropriate service and advice to assure that site quality systems are in place for regulatory compliance. Incumbent must assure that quality systems and programs such as internal audits, annual product reviews, stability, procedures, change controls, gap analysis, complaints, and other are in compliance with GMP regulations. This position must comply with all Security Guidelines, Environmental Health and Safety regulations and current Good Manufacturing Practices required by the job function. the incumbent works with minimum supervision and additional working hours, when required. 1. Assures the site quality systems are in place to avoid any possible regulatory compliance situation at the Site.
2. Manages the different quality systems and programs established at the site such as but not limited to Change Control,
Packaging change controls, Stability, Policies and Directives, Gap Analysis, Customer Complaints, TrackWise System, Site Gatekeeper, Regulatory CMC, Internal Audits, Document Control, External Audits, Annual Product Quality Review, and others handled by the Compliance areas as assigned.
3. Prepares Annual Product Quality Reviews report for each pharmaceutical finished packaged and bulk drug products manufactured at the Site as per established timelines.
4. Reviews and prepares regulatory documentation intended for government regulatory agencies (e.g. FDA), such as master files, new and existing product registrations, regulatory submissions, foreign countries registrations, certificates, etc.
5. Reviews, evaluates and approves plant operating documents such as SOPs, change control, qualification reports, CAPA, and process deviations and maintains documents in an organized and traceable manner.
6. Evaluates specifications, documents, protocols, registrations and recommends actions to assure regulatory compliance.
7. Provides assistance in managing all aspects of regulatory and corporate inspections and participates actively during inspections and audits including performing readiness exercises before and during inspections/audits.
8. Evaluates and recommends lots to be placed on stability, evaluate trends, and performs investigations when required.
9. Ensures compliance with procedures, policies and directives to avoid regulatory issues performing Gap Analysis on Client documents and observational findings from the pharmaceutical industry.
10. Provides advice and service to all operating departments to assure compliance with cGMP's and other regulations.
11. Investigates customer complaints, issues the corresponding reports indicating possible cause and recommending solutions.
12. Conducts and/or prepares training materials on GMP topics.
13. Performs formal internal audits and pre-approval inspections of manufacturing, laboratory and warehouse operations for cGMP's compliance and, reports and follows up on observed deficiencies on a regular basis.
Source : TechDigital
