Manager Quality Assurance

Roche (Pharmaceutical Company) are looking for Manager Quality Assurance for Karachi office.

Purpose

  • Responsible for overview of quality function of Affiliate, CO, including their audit and assessment from time to time.
  • Responsible to Report any product complaint associated with Adverse Event to Local Safety Responsible.
  • Responsible to initiate product complaint in Trackwise GPCS, DMS or GIM.
  • Responsible for investigation of Technical, disposition of Complaint Sample and Complaint Closure.
  • Manage all activities of the Quality Assurance Department for Roche Pakistan Limited.
  • Responsible for all activities of Quality Assurance Department to ensure compliance with company, and local regulatory requirements.
  • Directly and indirectly responsible for all activities of Quality Assurance department.
  • Responsible for Investigations and troubleshooting of any deviations as well as execution of process validation.
  • Responsible for Affiliate Risk Analysis, monitoring of root cause investigations.
  • Responsible for preparation of CAPA plan in case of any deviation and monitoring of CAPA effectiveness on implemented CAPA according to agreed actions with long span of time.
  • Responsible for Inspection and Release of Lot and Batches.
  • Responsible to report incident/ accident immediately to SHE department. Attend/ complete all requisite on-line and F2F trainings (Role specific, Safety Responsibility and Compliance) within specified time limit to ensure the learning outcome after the training has been implemented.
  • Identifies, collects and immediately reports all safety related information on Roche products to Local Safety Responsible as per Roche requirements and local regulations
  • Responsible for maintenance of records (electronic and physical) as per the Local SOP.
  • Responsible for oversight of Quality Operations of Third Party service provider as per Quality Agreement

JOB ACCOUNTABILITIES

  • Writing of Deviation report, Investigation report regarding any GMP/GDP deviation.
  • Validation (oversight) activities with respect to applicable systems.
  • Change control initiation, coordination and management. Designated role is change control coordinator.
  • Liaison / facilitations of inspections by Federal / Provincial Regulatory Authorities.
  • Disseminate information and implementation of corporate Pharma Manufacturing Standards. GWPs, GSPs and GDPS , guidelines, directives, SOP’s and documentation.
  • Handling of complaint management system in Track Wise GPCS, DMS & GIM.
  • Review / approve Deviations & investigations report writing.
  • Conduct / facilitate Internal Audits of Roche Pakistan Limited.
  • Implement (oversight) Qualifications / validations & transport validations cold Chain program concerning the products.
  • Liaison with National Control Laboratory, Islamabad for lot release of Biological Products.
  • Handling of products complaints & investigation report move to QA.
  • Maintain Site Master File and Quality Manual.
  • Track-Wise GPCS and DMS
  • Receipt of Complaints from Distribution department, drug inspectors, from global complaint managementor any other source and reply to them once the investigation is complete.
  • Logging complaints of Roche products on TrackWise.
  • Investigation, recording and analysis of Complaints
  • Inform Complaint Management of the Manufacturing site in case of imported products.
  • Record keeping and up-dating logbooks.
  • Handling of temperature recording device (TempTale Data logger) used for monitoring the cold chain transport and release of Inbound deliveries .
  • Checking for compliance with ValDAM and approving the consignment
  • Contact Global complaint management in case of noncompliance. Following the respective SOP.
  • Attend / complete all requisite on-line and F2F trainings (Role specific, Safety Responsibility and Compliance) within specified time limit

Additional Responsibilities

  • Responsible to report incident / accident immediately to SHE department. Attend / complete all requisite on-line and F2F trainings (Role specific, Safety Responsibility and Compliance) within specified time limit to ensure the learning outcome after the training has been implemented
  • Responsible to own the SHE goals as individual goals and play his/her part to achieve the goal in line with startegies/ action plan.
  • Identifies, collects and immediately reports all safety related information on Roche products to Local Safety Responsible as per Roche requirements and local regulations
  • Responsible for maintenance of records (electronic and physical) as per the Local CoreMap policy.

Job Specification
EDUCATION

  • Doctor of Pharmacy (Pharm. D.)
  • Master in Business Administration (Supply chain & Marketing) will be preferred

Experience & Knowledge

  • At least 2 years of professional experience in Quality Assurance
  • Experience in the pharmaceutical industry is mandatory
  • Intense Cold Chain And Cool Chain product information
  • Extensive knowledge about Validation and Calibration.
  • In depth knowledge of Local Regulatory Laws.
  • Deviation and investigation Reporting should be an additional experience.
  • Experience of liaising with other internal departments e.g. Marketing, Medical, Supply Chain, Logistics and Customer Services.
  • Has trained employees on Quality Management and Roche Good Manufacturing Practices.
  • Experience of managing Key Opinion Leader relationships
  • Good business/commercial understanding
  • Relevant knowledge on ICH GMP, GDP and regulatory requirements
  • Experience in temperature Mapping and Data loggers.
  • Knowledge of Artworks and Labelling Compliance
  • Relevant scientific knowledge.
  • Fluency in English written and verbal

COMPETENCIES

Roche Leadership Competencies

  • Strategic Agility
  • Decision Making
  • Technical & Business Expertise
  • Communication skills
  • Achieving Results
  • Teamwork and collaboration
  • Feedback & Coaching