Qc Coordinator

2 weeks ago

Durban, South Africa Cipla Full time

**Division**:
Quality

**Department**:
Quality Control

**Employment Type**:
Permanent

**Job Purpose**:
The incumbent is responsible for the management of the calibration schedule of the analytical instruments in the QC lab and in the IPQA. To ensure instruments breakdowns are timeously resolved with internal and external support. Initiation of URS and perform analytical and scientific rational for equipment procurement. To perform administrator function for some laboratory equipment.

**Accountabilities**:

- Responsible to ensure use of instruments and equipment that is meeting established performance specification and are properly calibrated.
- Responsible to set parameters of instrument / equipment as given in specification Responsible to ensure completeness of entries of all the tests performed and compilation of relevant data before submission for review.
- Involvement in the impact evaluation of instrument / equipment breakdown or calibration failures on previously released samples.
- Planning for calibration of equipment’s to ensure adherence to the calibration schedule and ensure traceability of respective calibration certificates.
- Ensures that all certificates for the test equipment used, are traceable to National Standards.
- Calibrates the machinery and instruments as per SOP’s.
- Ensure calibration procedures are in place as per manufacturer's specification.

**Accountabilities 2**:

- Liaising with vendors for calibration, repairs and breakdown equipment to reduce down time.
- Ensure that every calibrated piece of equipment has a calibrated label attached to it with relevant details of dates of calibration and next due date clearly stated.
- Liaise with QC and relevant parties for the availability of the machinery to be calibrated approximately a month before due dates, where possible.
- Liaise with contractors and ensure that equipment that are contracted out for calibration is done as per compliance SOP.
- Provide support in resolving laboratory investigations, deviations and developing CAPA’s as assigned.
- Ability to carefully review analytical data and resolve issues (follow up on corrections/mistakes identified).
- Ability to manage time and meet deadlines with multitasking activities.
- Ability to multitask and communicate work status and issues to management.
- Draft SOP for the respective equipment in the QC lab and where required IPQA.

**Accountabilities 3**:

- Generate URS for new equipment
- Generate CAPEX for QC equipment and IPQA where required.
- Draft qualification Protocols and perform qualification of instruments with service
- providers where possible
- Review of draft SOPs, WIs, received for reviews.
- Follow all cGMP/PICS and regulatory requirements.
- Review, evaluation, and implementation of pharmacopoeia changes.
- Instrument breakdown impact evaluation.
- Perform QMS ( Change control, deviation, and GXP) activities to ensure
- Compliance in line to the business requirements.

**Accountabilities 4**:

- To ensure compliance with current Good Laboratory Practices as laid down in the Quality Control procedures.
- Maintenance or upkeep of Laboratory working area i.e. good housekeeping.
- Following the laid down safety precautions while working in the laboratory.
- Maintenance of personal protective equipment’s and adherence to safety measures in the laboratory.

**Education Qualification**:
National Diploma/ Btech Degree and or BSC in Analytical Chemistry

**Relevant Work Experience**:
2-5 years in a pharmaceutical production environment.

**Competencies/Skills**:

- Collaborate to Succeed- Lead with Empathy- Innovate to Excel- Strong Domain Knowledge- Perform with Accountability- People Management- Act with Agility**Job Location**:
**Shift Hours**:

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