JOB DESCRIPTION:
Provide support to Quality Control Manager in managing QC activities related to Cleaning Validation, Computer System Validation and Annual PQR process.
Major Responsibilities:
- Prepare PQR (product Quality Review) Annual plan and implement it in timely manner.
- Collect PQR related data from all stakeholders, review and analyse data and prepare PQR report.
- Share PQR findings / observations / trends with respective sections and Senior Management for appropriate CAPA/recommendation.
- Cleaning Validation
- Preparation of Cleaning Validation Master Plan (CVMP), protocols and reports with worst case selection as per recent guidelines and products at site.
- To ensure Cleaning Validation activities related with Products, Processes, and Equipment.
- To provide support to QC in conducting glassware cleaning validation.
- Conduct Cleaning validation and revalidation via preparing cleaning validation protocols, relevant documentation as per Master plan.
- Perform and manage cleaning validation sampling activities along with QA support.
- Revision of cleaning validation schedule as per production and supply priority as per their request and consensus.
- Computer System Validation:
- Prepare annual Computer System Validation Master Plan (CSVMP) of QC equipment and ensure adherence, prepare, and communicate monthly computer system validation plan to all stake holders.
- Prepare protocols and reports of computer system validation and to perform computer system validation activity accordingly.
- General Responsibility:
- Review of applicable policies and align SOPs (related to PQR, cleaning validation, and computer system validation).
- Implementation and compliance of all the SOPs and applicable policies and procedures.
- To review and complete change control tasks with respect to Cleaning Validation, Computer System Validation and PQR.
- To prepare impact assessment and risk assessment as or when required.
- To provide support to other sections/departments with respect stability program and any data required for to PQR, Cleaning Validation, and Computer System Validation
- To review AQR LL, HPR and other quality projects for assessment and actions related to above-mentioned sections.
- To participate in self-inspection, Regional, Divisional and AQR Audits as an SME of above-mentioned sections.
- To implement Audit CAPAs of above-mentioned sections in timely manner
- Any other responsibility, assigned by Quality Control Manager or Head of Quality Assurance.
- As an SME support will be provided to Stability Section when required.
Education/Knowledge & Experience:
- M.Sc. Chemistry / Pharm-D
- 8-10 years’ experience in the same capacity
- Knowledge of requirement for QC/QA activities, Cleaning Validation, Computer System Validation problem resolution skills and other all activities taking place in QC/QA including knowledge of Annual product quality review.
- Knowledge regarding Validation and Facility etc.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Manufacturing
DIVISION:
EPD Established Pharma
LOCATION:
Pakistan > Karachi : Opp: Radio Pakistan Transmission, Hyderabad Road, Landhi
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
