Assistant Manager Validation
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Job Location:
Monthly Salary:
Posted on:
23 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Position: Assistant Manager Validation
Reporting to: Senior Validation Manager
Division: Established Pharmaceutical Division - Operation
Location: Karachi -Pakistan
Job Summary:
To liaise with Sr. Validation manager for providing support to Validation Review Board (VRB) and Validation Execution Team for Validation and Qualification activities related with Products Processes Equipment Utilities Facilities.
Major Responsibilities:
- Implementation and compliance of all the SOPs and EQD/AQR Policies and Procedures related with Validation/Qualification.
- Develop review and execute Cleaning Validation Protocols (IQ/OQ/PQ).
- Establish and justify MACO/Acceptance Criteria for product residues detergents and microbial contamination.
- Perform risk assessments for cleaning processes and equipment.
- Coordinate sample collection and ensure correct analytical testing (TOC HPLC swab/rinse analysis).
- Prepare Cleaning validation protocol analyze validation results and prepare comprehensive Cleaning Validation Reports.
- Maintain and update the Cleaning Validation Master Plan (CVMP).
- Support qualification of equipment utilities and CIP/SIP systems.
- Investigate cleaning failures deviations and trends; implement CAPAs.
- Collaborate with Operations Engineering QA and QC on continuous improvements.
- Ensure compliance with cGMP FDA EU EMA ICH Q7 and internal standards.
- Train operators on cleaning procedures and validation practices.
- Participate in regulatory audits as the Cleaning Validation subject matter expert (SME).
- Performance of Validation/Qualification activities related with Products & Processes Equipments Utilities Facilities.
- Performance of Revalidation/Re-Qualification activities as per Validation Master Plan.
- Approval and filing of Validation documentation (Validation Change Request Design Qualification Protocols Reports etc.).
- Ensuring appropriate training of VRB and Validation Execution Team and keeping the records.
- Any other responsibility assigned by Sr. Manager Validation or Director QA.
- Planning and scheduling of cleaning validation activities incoordination with all concern department.
- Develop and maintain CSV deliverables: Risk assessments validation plans IQ/OQ/PQ protocols test scripts and summary reports.
- Perform 21 CFR Part 11 and Annex 11 compliance assessments for electronic systems.
- Manage system lifecycle documentation: system inventory user access management periodic reviews change controls.
- Collaborate with system owners IT QA and vendors during implementation and upgrades.
- Review and approve vendor documentation: FRS/DS FAT/SAT configuration specs.
- Support audit trails backup/restore testing and cybersecurity controls.
- Investigate system deviations perform impact analysis and support CAPAs.
- Provide SME support during regulatory inspections and internal audits.
- Ensure continuous compliance through system monitoring revalidation and periodic assessments.
- Preparation of Computer System Validation Master Plan Periodic Review Protocol and Report.
Education/Knowledge & Experience:
- Science Graduate/Master; preferably MSc Chemistry/Microbiology/Pharm D
- 4-5 years experience in the same capacity
- Knowledge regarding Validation of Process Equipment Utility and Facility preferably in a multinational Pharmaceutical.
- Proficient in MS Office
- High Analytical Skills
- Analytical Skills
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EPD Established Pharma
LOCATION:
Pakistan > Karachi : Opp: Radio Pakistan Transmission Hyderabad Road Landhi
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Manager
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
