Assistant Manager - LOC Quality
- GlaxoSmithKline
- Not Specified
- Mumbai
- 4 years ago
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Job Description
Job Description :
Site Name: India - Maharashtra - Worli Mumbai Posted Date: Aug 17 2021 LOC PRODUCT COMPLAINT HANDLER . Route the customer communication . Log the complaint in a maintained register/system (as applicable) and assess criticality. . Follow-up with customer and request sample unless justified that the sample is not required. . Route complaint and any sample to the investigating site based on the defect observed. . Assess/review if complaint is associated with HSI and if it is, inform the local Pharmacovigilance (PV) representative within 24hrs through the Regional AE Reporting Mailbox. Maintain any Safety data cross-references and forward any follow-up information to the local PV representative through the Regional AE Reporting Mailbox. . Ensures that any HSI data cross-reference is maintained . Reviews the local register for any other similar complaints from the role of product complaint handler. . Forward complaints which are not related to product quality to concerned stakeholders (e.g: Complaints on market shortages to distribution department, AE & SAE related to Medical) . Perform local trending of complaints and escalate adverse trends to Safety and/or Quality functions. . Perform monthly reconciliation of HSI with the with the local PV representative through the Regional AE Reporting Mailbox. . Escalate actions which may be overdue or at risk of non-compliance to LOC quality council. . Carry out an annual review of the process so that it continues to be effective and to identify improvement. COUNTERFEIT HANDLER: . To log the received suspected counterfeit product and record the information received. . To forward the suspected counterfeit sample and received information/ documents to the manufacturing site for investigation . Call for LIC/PIRC if the site confirms of confirmed counterfeit . Coordinate with Legal Brand Protection (LBP) to report the suspected counterfeit. . To escalate to Quality council as appropriate TOLL FREE SERVICE COORDINATOR . To ensure SOP in place and in use. . To ensure third party employee are trained on applicable trainings . To ensure third party included in IBM universe and schedule . Responsible to take Monthly KPI from third party . To provide the updates to quality council . To support third party if they have a confusion or doubt in the communication received. REPACKAGING REQUEST CO-ORDINATOR: . To review and approve repacking request form. . To ensure that repacking is conducted in an approved location. . To update details in log. . To ensure local regulatory and quality requirement are met. . To approve of text matter of overprinting or stickering. . To decide on the application of special features like re application of tamper evident stickers due to its opening of secondary packs as applicable. . To ensure that batches are released post repacking activity and all related actions and documents are closed . Carry out an annual review of the process so that it continues to be effective and to identify improvement. OTHER: . To perform the QMS gap assessment for the relevant system, where required. . Preparation, revision of LSOPs / Regional LSOPs as per requirement. . To perform MM, IBM, Third party audits, Scoping visit after appropriate qualification. . Identify and log risk and devise, monitor and implement appropriate mitigation plans. . To collate and submit data for KPI management and other governance forum like QC, RQC, RMCB etc. . Complete mandatory Mylearning trainings by the due date. Perform a job only after completion of training on that topic. . Ensure that all internal procedures and systems which are in LOCQ are followed and complied with. . Any additional responsibility assigned by the line manager as and when required. Number of Direct Reports: NIL Educational Background Post Graduate in Science / Pharmacy Minimum Level of JobRelated Experience require . Preferably 5 plus years experience in Quality Assurance in Pharmaceutical industry. . Having adequate knowledge of complaint management system and experience in handling of complaints as per quality assurance function Other Job-Related Skills/Background . Good knowledge of documentation / regulatory requirements and quality management system. . Breath knowledge in quality systems principles and practical application. Good knowledge of quality management tools. . Demonstrated sound decision-making process, based on the facts and data, and application of Risk management principles. . Exposure and competencies with respect to multiple dosage forms. . Excellent verbal and communication skills, collaborative team member and team leader. . Demonstrated ability to effectively multi-task. . Ability to excel in execution. *LI-GSK Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. 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Employement Category:
Employement Type: Full timeIndustry: PharmaceuticalFunctional Area: Quality ControlRole Category: DocumentationRole/Responsibilies: Assistant Manager - LOC QualityContact Details:
Company: GlaxoSmithKline PteLocation(s): Mumbai+ View Contact
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