Description
Details
Our Client needs top rated Quality Assurance Manager to resume immediately. The incumbent will be part the team at the Microbiology Section and will be reporting to the head of Head - CQA in Lagos.
Responsibilities
Covers but not limited to following:
Overall Responsibility of QA & QC Dept.
Reviews, Approval & execution of SOP’s, reviews & Approval of Manuals, Policy Documents.
Overall responsible for Developing and Implementation of the company QMS.
Review & Approval of APQR, SMF, VMP, PV & CV as per SLPL QMS policy.
To ensure adherence to Validation Plan. Assessment & Approval of Qualification, Validation and calibration Activities.
Identification & Assessment of Risk and execute the Mitigation plan.
To ensure investigation of each market complaint & ensure effective implementation of CAPA &. Conduct the periodic reviews.
Review & Approval of Deviations, Rejections, OOS, OOT, and ensure CAPA.
To prepare and execute effective Training plan for staff & workers. To impart training on cGMP, GLP as per updated guidelines and create awareness amongst peoples. To evaluate the effectiveness of training of subordinates at regular intervals.
To prepare & implement self inspection program & ensure all time preparedness of plant for external audits.
To monitor Cleaning, Sanitation & hygiene in all departments and ensure all time GMP compliance of plant.
Evaluate stability study observations and take-up necessary actions.
Release of Finished Product for Sale.
To maintain good discipline work culture & cohesive team in the department.
To control budgetary expenses of department.
Effective coordination with various departments.
Any other responsibility given by Head CQA.
Person Specification
Qualification: B.Pharm / M.Pharm / M.Sc
Total Experience: 12 to 15 Years
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Job Description
We are in need of top rated Pharmaceutical Microbiologist to resume immediately. The incumbent will be part the team at the Microbiology Section and will be reporting to the head of Quality Control in Lagos.
Responsibilities
Microbiology Section - Planning and work allocation for. Micro activity, if required
Ensuring the quality and integrity of all GxP data and documentation generated.
Monitoring of sampling activity of incoming Raw materials, Packing materials & Microbiological samples.
Microbiological testing & monitoring of Finish goods, Raw materials, packing materials,
Water samples & environments.
Ensure fully Engagement and Involvement regarding awareness, clarity maintained related to data integrity.
Knowledge of EHS – Demonstrates basic knowledge of environment, Health and safety requirements within work area in order to comply to all set standard, identify and escalate potential hazards.
Investigation Skills – Demonstrates expert knowledge of investigation procedures and tools, domain knowledge, impact assessment and implications on related areas in order to have comprehensive investigation to avoid repeat of issues/incidents, review trends and understand issues impacting organization and design CAPA.
Calibration of Equipments / Instruments as per the planner.
To follow & maintain the practices of cGMP & GLP in QC Dept.
Co-ordination with Internal & External customers.
All quality control related documents, records, raw data shall be reviewed.
Review the documentation of Deviations, change controls, Out of specifications if any.
Execution of Analytical Method Validation of Microbial tests.
Trending & review of microbial analytical data
Investigation of OOS, deviation of Raw, packaging and finished material analysis.
Imparting the Internal training activities for Quality control personals.
Monitoring the calibration / validation planner for Instruments / Equipment.
The procurement of Microbial cultures, medias, reference standards from authorized supplier and laboratory chemicals
To prepare and update the Testing procedures and Specifications and related documents.
Destruction of respective records & QC Samples like Retention samples of Raw Materials, analyzed samples.
To comply Internal and External Audit Observations.
Issuance of QC analytical data sheets
Evaluation, validation and monitoring of critical control points with respect to process as part of cGLP/GMP requirements.
Preparation and destruction of Medias.
Preparation of Microbial inoculum and growth promotion test as well as preparation & maintenance of sub cultures.
Person Specification
Qualification: M.Sc (Microbiology)
Total Experience : 5 to 7 Years.
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