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Contract QA Release Pharmacist

Job Overview

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Job Description
To act as the single point of contact for QA product releases and ensure that all product is released in accordance with local health authority requirements and global best practises. Furthermore, support the quality team in ensuring that all quality standards and specifications are maintained.

MAJOR ACCOUNTABILITIES:

• Compliance: To adhere to GxP and Quality standards, requirements and procedures as deter-mined by local regulation and Global Operating Procedures.
• Stock Availability: To ensure stock release is done timeously and in compliance with local requirements.
• Act as a QA Release Process Owner
• Business Continuity: To support local business in meeting objectives and continuity of services.

KEY PERFORMANCE INDICATORS

KEY RESULT AREA 1: QA Release Process Owner

Objective: To ensure stock release in accordance to local regulations, quality standards and within appropriate lead times.

• Release documentation (BRCF) up to date and maintained within agreed timelines
• Batch release documentation (CoA / CoC, temperature data and PIT results) reviewed and approved as per release SOP
• Batch release recorded in appropriate systems
• Batch release notifications sent to relevant stakeholders
• Liaise with external parties (e.g. DSV, UPD, M&L, and SABS) involved in release timelines to ensure required timelines are met.
• QA launch support to ensure that products can be brought to market within business time-lines and in a compliant manner
• Completion of method transfer as needed for method changes, newly launched / re-launched products
• Attend cross divisional supply meetings (e.g. S&BP, launch) and provide QA input as needed
• Reference standard and column management for all local testing activities
• Providing GxP input across the organization related and partnering with departments in or-der to provide guidance in conducting business activities in scope of QA in a compliant manner.

Performance will be satisfactory when:

o Products meet the quality release requirements
o Products are released within the required timeframes
o No long term stock outs resulting from QA
o No QA related delays to product launch

KEY RESULT AREA 2: Compliance

Objective: To ensure alignment to Quality Manual, Global quality mandates and Local health authority requirements and policies.

• Product quality assurance – Support other Pharmacist in periodic completion of Product quality reviews and batch manufacturing document review as per local SOP
• Ensure Good Documentation practices are adhered to at all times.
• Exception management – Raising of deviations, quality events and participate in escalations as required. Actions related deviations, QE, audits and self-inspections be handled within the required timeframe.
• Maintain all QA tracking documents for internal tracking purposes.
• Create, update and maintain all third party oversight documentation – PSA, QAA and Risk Assessments.
• Audits and self-inspections – Participate as needed with internal and external audits and inspections
• Conduct internal and external GxP related training (e.g. complaint reporting, data integrity) as required.
• Conduct trending activities as required by AQMR and QRB (complaint trending, returns and receiving deviations).

Performance will be satisfactory when:

o Assigned PQR are completed as per set timelines
o Assigned BMRs are completed as per set timelines
o Assigned Method transfers are completed as per set timelines
o Assigned Change Notification / Change requests are completed as per set timelines
o All AQMR and QRB related information is available when needed.
o Complaints are reported within required SOP timelines.
o All audit and self-inspection are completed as per local plan
o All third parties are maintained as per requirements

KEY RESULT AREA 3: Act as Quality Management System owner

Objective: To provide a high level of quality related support to both internal and external customers relating to:

• QA tasks and maintenance for relevant QMS – Tasks include: recording, tracking, updating, reviewing, approving and close-out on Trackwise, AQWA, ESOPD D2, Up4Growth and SHAPE.
• Responding to requests adequately, satisfactorily and timeously.
• Support the business with all QMS related enquiries in a timely and efficient manner.

Performance will be satisfactory when:

o All requests have been attended to timeously and adequately.
o Support has been provided to the business on quality matters.
o All QA systems are up to date and compliant

KEY RESPONSIBILITY AREA 1: CORPORATE GOVERNANCE

OBJECTIVE:
To take responsibility for Corporate Citizenship within the sphere of influence and control, and to enforce the Code of Conduct and monitor employees’ activities within the spirit of the company’s policy.

Performance will only be satisfactory when:
1. There is compliance with all aspects of the Code of Conduct / Corporate Citizenship / SP3Policy.
2. Corrective action is taken where deviation is noted.
3. Non-compliance is reported.
4. There is compliance to HSE requirements
5. There is compliance to Corporate guidelines & SOPs
6. All allocated training is completed in a timely manner.
7. All adverse events and complaints are reported as required by corporate guidelines and SOP’s.

KEY RESPONSIBILITY AREA 2: ORGANISATIONAL RELATIONSHIPS

1. The IPQS QA Pharmacist reports directly to the Quality Unit Head (IPQS).

2. The IPQS QA Pharmacist has a functional working relationship with:
• Regulatory Affairs.
• Supply Chain
• Medical Affairs
• Pharmacovigilance
• Global QA
• Marketing and Sales

KEY RESPONSIBILITY AREA 3: AUTHORITY LIMITS

Has the full authority to undertake the tasks necessary to achieve the key results of the position, provided it is within the company policies and procedures and guidelines as set down by the direct manager.
Minimum requirements
Languages: English and Afrikaans

Experience:
B. Pharm degree.
Registered with the South African Pharmacy Council.
Minimum of 1 years in the pharmaceutical industry (quality assurance, quality control, registration or production) or a directly related field.

Technical Knowledge:
Professional Knowledge: Good knowledge and understanding of GMP, quality systems and quality practices. Product release, documentation, process and third party management. High compliance.
Soft Skills/Behaviours: Planning & organising, analytical, communication and interpersonal skills.

Contract till December 2021.

Send your CV to vicki@medicalcareers.co.za

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