New Post Gauteng – Pretoria – near the suburbs of Lynnwood/Montana Park/Silverton:
A QA Manager is needed for a Pharmaceutical Production Environment of Complementary Medicines:
- Salary: Gross CTC is up to R55,000 per month (depending on experience) plus a performance based bonus. Provident is included in CTC.
- Working hours: Mon-Fri: 8am-4pm.
- A min of 2 years of production experience – i.e. must have either QA, Production or RA experience from a pharmaceutical manufacturing environment.
- A min of 2 years of management and leadership experience.
- Must have an excellent knowledge of pharmaceutical manufacturing, packing and Quality Control processes. Should know quality management systems, quality management reviews, risk management, and risk assessments.
- Start date: Dec/Jan
- Leave days: 18
- Job Objective: Ensure that product is manufactured, packed and tested to meet requirements for quality, safety and efficacy; and that release is performed after a thorough review of batch records and analytical reports
- Job Description:
- Further developing, maintaining and practically managing all aspects relating to a pharmaceutical quality assurance system
- Ensuring the effective and efficient functioning of the Quality Assurance Department and its personnel
- Ensuring good communication between the Quality Assurance Department, the Quality Control Laboratory, Production and the Supply Chain including stores
- Corresponding with service providers and 3rd parties concerning quality, non-compliance and queries
- Ensuring that structured GMP, GWP, GLP and GPP training is planned and carried out
- Performing and assisting with internal and external facility audits
- Be able to oversee the creation, review, updating and implementation of all Master Documentation
- The issuing of unique Item codes
- The creation of BOMs/BIL’s
- Maintaining and reporting with regard to Change Control, Re-works, Out of specs, Non-conformances and CAPA’s
- Carrying out Annual Product Reviews (APRs)
- Reporting monthly to a Performance meeting regarding the status of the Quality Assurance System
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New Post Gauteng – Johannesburg – Midrand:
A Responsible Pharmacist is needed for a Pharmaceutical Applicant Company as follows:
- Gross Salary: Up to R62,500 CTC (depending on experience) which includes a medical aid, and provident (only after 3 months) + a performance based bonus + petrol card
- Working hours: Mon-Fri: 8am – 4:30pm
- Start date: 1 December
- Requirements: A min of 2 years QA experience from industry + Responsible Pharmacist or Deputy RP experience. Manufacturing, Regulatory, and Marketing & Sales experience is advantageous.
- Job Purpose: The Responsible Pharmacist is responsible to the CEO for setting up and directing a Quality Assurance system that ensures the continuous sale of safe, effective products consistent with approved procedures and standards. Responsible for interfacing with Regulating bodies. The products cover scheduled products (originator and generics), OTCs, and medical devices. The Responsible Pharmacist will need to communicate with overseas and local manufacturers. Needs to interact with all departments including Regulatory, Sales, Marketing, Training, Medical Affairs, and Finance.
- Summary of Job description:
- Formulating, setting up and directing a Quality Assurance System
- Setting up a sampling and testing protocol for all finished products and retention samples
- Reviewing / evaluating batch documents for completeness, correctness, accuracy for the final batch release of all Applicant products
- Releasing or rejecting all finished goods to market
- Setting up and approving test specifications, test methods, sampling methods
- Managing 3rd Party Contracts in terms of service providers for pest control, testing and analysis, contract manufacturing agreements and distribution agreements
- Conducting annual product reviews
- Conducting internal audits, supplier audits and 3rd party audits
- Proper control of disposal or destruction of medicines
- Providing Sales and Marketing support
- Final approval and sign off of printed promotional material, artwork for printed packaging material
- For Pharmacovigilance – dealing with product complaints, recalls, adverse event reporting, and technical complaints
- Application of NAPPI codes, Single Exit Price for all new products and submission of Single Exit Price Adjustment annually
- Leave days: 18 days
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