
Manager QA and Compliance
2 days ago
Key Duties & Responsibilities
QMS section:
- Work as a final approver for all quality and cross functional documents like but not
limited to SOP, Formats, Batch records, Analytical records like Specification, Method
of analysis etc.
- To act as a final approver for different Quality and Service agreements with
customers, vendors and service providers and to ensure the adherence of the same
during routine operation and execution.
- To ensure all the team members are executing the task and works within the defined
job roles in day to day routine quality operations activity.
- Primarily responsible for assurance of quality matrix of the Ahmedabad site by
assuring the quality management system like Management of Change controls,
Management of Market complaint, Deviation Management, OOS management are
been done per the define process work flow.
- Primary responsible for managing and handling audits (Internal, Customer,
Regulatory and Certification Body).
- Management of all CAPA for internal and external audit, including CAPA taken
against any investigation with tracking, effectiveness verification and closure.Page 2 of 3
- To ensure Quality Matrix Monthly/Quarterly/Half yearly and Annual, preparation and
compilation.
To ensure monthly trend preparation of complaint per the procedure.
Management and procedural execution of Management review meeting.
To be responsible for batch release of finished products.
Responsible for ISO, NABL, FSSC2200, EXCiPACT training and certification
To lead product permission activity with State FDA and CAA wherever applicable.
Responsible for Vendor audit for RM and PM and New PM vendor development
process
To ensure operational support to production, packing and engineering teams.
Responsible for contract manufacturing quality and process oversite wherever
applicable.
- Marketing request handling and resolution for queries received from diff customer or
regulatory bodies.
Management of all quality system documents but not limited to SMF, IMS , VMP ect.
To act as an administrator and executor whichever is applicable for allocated
computer systems used in GMP operations like Mastercontrol Software.
- Responsible for complete stability management program for the applicable product
grades.
- To ensure the development of new product and launches per the required business
flow, grade and regulatory and customer compliance.
Education
B.Pharma/M.Pharma, Msc. Chemistry, B tech or M tech with biotechnology or chemistry.
Experience
12-13 years of experience in Pharmaceutical, API or excipient regulated industries.
Competencies & Skillsets
Functional / Technical
Behavioral
- Technical knowledge of
API/Excipient/Pharma manufacturing and
packaging with technical writing skills
- Indepth knowledge of Document and
data management, Quality Management
System, Investigation tools and RCA
tools knowledge and implementation.
Audit handling and auditing skills
SOP writing and review skills
Training and management skills
GMP regulatory guidance knowledge
and implementation skills.
1. Strategic Leadership skills -
able to lead the team
strategically.
- Critical Thinking - Objective
analysis and evaluation in
order to form judgement.
- Result Orientation -
Accountability and meeting
organizational objectives.
- Problem Solving - A knack to
solve problem with an
objective approach.
- Effective communication and
counseling skill
-
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