Quality Assurance Pharmacist at Cipla

Job description

Purpose

To ensure that Cipla Medpro operates in compliance with Cipla’s Quality Management System requirements, all of the provisions of Act 101 of 1965 (Medicine and Related Substances Control Act), Act 53 of 1973 (Pharmacy Act) and all Regulations to these Acts, guidelines as well as Good Practice guidance documents pertaining to manufacture, warehousing and distribution of medicines and other health related products.

• Supports the effective implementation and management of the Quality Management System (QMS)
• Supports the development, effective implementation and review of the relevant QMS processes.
• Drafts new SOP’s, review new SOP’s drafted by other team members, to review SOP’s requiring periodic revision as well as to review SOP’s that have been updated.
• Assist with the review and revision of the Site Master File and Quality Manual.
• Assist with or Performs Quality Risk Management reviews as part of the FMECA team, in accordance with the relevant SOP.
• Identifies new opportunities within the QA department to continuously improve on the QMS.
• To assist/facilitate the implementation of the ISO 13485 Standard requirements.
• To identify and drive process simplification and cross functional integration through the liaison with key stakeholders.
• Review of Non-conformances (NC), Deviations and Out of Specification/Trend (OOS/OOT) notifications
• Reviews and evaluates NC/Deviation/OOS/OOT notification upon receipt.
• Discusses the impact of the notification with the relevant second reviewer.
• Collaboratively decides on action plan / path forward on behalf of the applicant.
• Ensures that the initiator of the NC/Deviation/OOS is responded to within the specified timeline.
• Ensures that further documentation is requested timeously, in support of final decision on NC/Deviation/OOS/OOT notification.
• Assists in regular status follow-ups of the NC/Deviation/OOS notification, as per time points specified in the SOP.
• Attends regular meetings with QMS Officer and QMS Manager to discuss open issues when necessary.
• Escalates concerns to QMS Manager and QA Director timeously.
• Drives all open NC/Deviation/OOS notification to closure.
• Provides pharmacist expertise on QA Product Complaints/Queries
• To intervene, assist and communicate directly with the customer on any QA product query/complaint requiring pharmacist advice, and to ensure that any issues relating to quality, safety or efficacy, regulatory compliance or business continuity are identified and escalated timeously.
• PQR Review
• To review and assess completed PQR Summary Reports and escalate concerns to the QMS Manager and QA Director, when necessary.
• Review of promotional material
• Reviews promotional material and launch letters against relevant legislation (Medicines Act, Marketing Code etc.), when requested by the QA Pharmacist, or in the absence of a second reviewer.
• Escalates areas of risk identified within promotional material item text/imagery, to QMS Manager as necessary.
• Systems management of internal CAPA`s
• Reviews and evaluates internal CAPA’s with CAPA team, upon the CAPA being raised.Discusses the impact of the CAPA with the QMS Manager and QMS Director to provide final approval.
• Where necessary, requests further documentation in support of the investigation into CAPA actions.
• Escalates CAPA concerns to QMS Manager and QA Director when required.
• General administration and support
• Assists with any reasonable duties as requested by QA management to ensure that the department is functioning optimally and meeting its set objectives and goals. These could include (but are not limited to) the following activities:
• Temperature Excursions
• MCC/SAPC Audit prep/responses
• Import/Export Permits
• Month-End Reporting & Investigative Reports
• QA Training
• Internal Auditing/Self Inspection
• Import Alerts/Warning Letters
• Halaal Suitability Studies