Chemical Manager

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