Responsibilities:
??Responsible?for?the?production?operations?to?ensure?that?safety,?quality?and?productivity?goals?are?met?in?compliance?with?EU,?US?FDA?and?CFDA?requirements?as?applicable.
Creates?the?Annual?Validation?Master?Plan?and?then?oversees?its?execution.?Validation?of?processes?and?cleaning,?and?qualification?of?both?new?and?existing?equipment.?Ensures?all?is?executed?in?accordance?with?company?procedures?and?regulatory?expectations.
Owns?departmental?SOPs?and?equipment.?Converts?the?Master?Schedule?into?the?Production?Schedule.?Provides,?updates?and?manages?towards?showing?minimization?and?optimization?of?production?costs.
Sets?departmental?cross-training?and?performance?expectation?and?coaching?subordinates?to?ensure?operational?compliance.
Accepts?responsibilities?for?deviation,?changes,?root?cause?analysis?and?quality?departmental?improvements.
Work?with?product?development?to?solve?difficult?technical?problems?and?coach?manufacturing?personnel?in?solving?technical?problem.
Other?tasks?assigned?by?Manager.?
Qualification?and?Job?Requirements:
??????????????????Have?experience?in?EU?and?US?FDA?inspection.
Bachelor?degree?or?above?in?pharmacy?or?related?field.
Rich?experience?in?management?of?final?handling?workshop?or?clean?area?in?pharmaceutical?enterprises.?
??????Ability?to?communicate,?coordinate?and?cooperate.
Good?English?listening,?speaking,?reading?and?writing?skills.