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Note- Candidates should
be from top Pharma Packaging Manufacturing or top Pharmaceuticals
Manufacturing company only.
Note - Candidate should
be from the DMF Certified Plant ( Type I, Type II, Type III) ONLY.
Job Purpose:
Responsibility and accountability for quality across the business. Guarantees the continual
compliance of quality standards for products and processes to ensure
component, consistency, and safety.
Major Duties &
Responsibilities:
1) Responsible for final quality
assurance. (Assist junior for smooth functioning of QC/QA roles).
2) Activity involved in the
implementation for rejections control & reducing customer complains.
3)
Prepare,
control, distribute, implement, and maintain the quality management system
documents including QMS, SOP, Formats, Work Instructions, policies to cover
the applicable standards (including as a minimum ISO 9001, EN ISO 13485, EN
ISO 15378, and others as per customer requirements)
4)
Structuring
Implementation of various activity, procedure & systems.
5)
To
attend various complaints and make CAPA.
6)
To
support production people by given knowledge about product critical
conditions.
7)
Work
as Customer representative on shop floor.
8)
Any
deviation observer should be identified and NCR to be Raise.
9)
Verification
of Customer complaint if any at the time of process of job.
10)
Prepare,
implement, and maintain organization’s quality objectives as per the
objective awareness matrix which clearly describes the primary and secondary
responsibilities of each defined objective.
11)
Plan
and conduct validation and verifications.
12)
Prepare
and release declarations as per customer requirements.
13)
Participate
in design and development of new products/process.
14)
Preparation
of required training materials, questionnaires, answer sheets
15)
When
applicable, review and release of batch manufacturing records/COA-COC to
ensure that requirements are met with before dispatch to customer.
16)
Review
Work Instruction, Formats, and other documents before issue to the various departments.
Provide necessary guidance to various departments to assist them to perform
their work as per the quality management system requirements.
17)
Verify
and assist with regular risk assessments; conduct risk assessment for QA and
RA for all department and maintain records.
18)
Identify
training needs for quality department and arrange/provide trainings
accordingly.
19)
Distribute
the QA and RA work amongst the department staff to ensure that the tasks
assigned are completed effectively.
20)
Any
trends observed through monitoring and measurement of product and equipment.
21)
Conformity
to the Identification and traceability requirements
22)
Dedicated
commitment for continual improvement and customer satisfaction.
Required Skill Set:
1) Should have Excellent knowledge of ISO
9001, EN ISO 13485, EN ISO 15378.
2)
Proven
leadership and management skills with the ability to optimize team
performance and development.
3)
Excellent
analytical and problem-solving abilities
4)
Results
orientated with ability to plan and deliver against project deadlines.
5)
Commercially
and financially astute with experience of managing budgets Technical mindset.
6)
An
appreciation of and an ability to positively resolve issues arising from
different cultures.
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