QA Release Pharmacist - Contract

Reference: CPT000545-CH-1A global pharmaceutical company is seeking a QA Release Pharmacist for a 10-month contract/project position.The Quality Assurance Specialist (Release Pharmacist) has responsibility to ensure all products are released for sale according to Good Manufacturing Practice (GMP) requirements and within set timelines.  The QA Release Pharmacist ensures quality standards, processes and specifications are in line with registered information and global GMP requirements Duties & Responsibilities Primary Responsibilities:

Management and oversight of the release of all finished, packaged products to the market Management and oversight of the release of bulk products and components for primary and secondary product packaging. Management and oversight of the release of fully packaged and imported products. Implementation of and adherence to global and Health Authority requirements for batch disposition. Adherence to release dates as per MBTR Ensure stability schedule is cascaded to the site and samples are sent to the stability hub as required. Ensure PITE submissions are completed timeously. Review and approval of CAPAs. CoP meetings for Topic 6.8; 3.6; and 8.1 Complete annual health assessments Review and implement all Quality Management System updates at site level Attend all production related meetings as required. Management of product retention samples. Batch documentation reconciliation and filing. Initiate and complete change controls Complete change control tasks as per due dates.

The QA Release Pharmacist is also responsible for:

Act as risk lead or quality representative in product quality risk assessments Liaise with DSV on all product related queries Act as a point of contact for queries from GHH Liaise with external quality assurance and the company's internal team on all Quality related issues. Act as Quality Representative in weekly Quality meeting. Respond timeously to all Quality related queries and requests  Participate in and lead {as required} meetings, problem solving sessions and strategy development plans with company representatives  Participation in Health Authority, global quality, internal, and external audits. Prepare audit responses and close out CAPAs as per due dates. Participation in deviation classifications and investigations, and Change Control Systems

Site Projects

Represent Quality end to end on all site projects, when required.

Qualifications:

Degree in Pharmacy Active registration status with SAPC

Experience

Minimum of 2-5 years in Pharmaceutical Industry Experience in SAP Experience in the Quality Assurance pillar Experience in Good Manufacturing Practices A good understanding of Health Authority requirements Excellent communications skills (written and verbal) Good analytical skills Effective time management Task and timeline driven

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.comShould you receive no feedback within 7 days, please accept your application as unsuccessful.